Powerful Community, Fresh Ideas

Kapil has over 20 years of life sciences experience in: data management, data architecture, product management and innovation, and strategy. In his current role, he leads three technology competency centers; testing, DM reporting and data review, and innovation and automation.

Lance has over 22 years of experience in biopharma, spending the last four years as Director of EDC & IRT Data Systems at AbbVie. Lance was co-lead for the Veeva Clinical Data Implementation at AbbVie in 2023, and throughout his career has been involved in multiple company and systems integrations.

Tracey holds a BS in biology and an MBA. She began her career as a clinical laboratory scientist before transitioning to work in pharma at Pfizer. For 11 years, she worked in scientific, technical, and management positions in non-clinical R&D. Tracey has been with AbbVie for 14 years, holding positions in diagnostics, regulatory, pharmacovigilance, and IT. Over the past nine years, she has worked on projects to automate safety reporting using robotic process automation and machine learning. She also led a successful implementation of Vault Safety in 2022 and now heads the Veeva Community of Practice at AbbVie.

Abhishek is a senior pharmaceutical technology leader with experience leading global technology transformation programs for companies such as Astellas, Novartis, and Boehringer Ingelheim. At Astellas, he leads the Enterprise Veeva Chapter, which includes platform governance and line leadership of all Veeva resources and associated capabilities. He also leads clinical trial operations technologies, including CTMS, eTMF, SSU, Site Connect, site contracting, payments, IRT, disclosure tools, patient engagement portals, and AI use case implementation.

Kate has 25+ years of experience in pharmaceutical development at mid-large size pharma, CROs, and clinical sites. In addition, with responsibilities for phases of trial delivery (phase 1-4) across multiple therapeutic areas, she has a robust background in clinical delivery. Through expanded leadership roles Kate has demonstrated success in developing and executing strategic plans to optimize trial operational efficiency, reduce cycle times, and maximize quality, all in a risk appropriate way to ensure regulatory compliance. As business strategy lead for clinical operational excellence at Astellas, she is responsible for leading teams covering clinical operation support activities in the areas such as clinical systems, compliance, study startup, and operational infrastructure.

Kevin is senior vice president of clinical development operations at Eikon Therapeutics, where he leads the functional areas of clinical operations, clinical data management, project and portfolio management, clinical quality assurance, medical writing, clinical R&D process, documentation and learning management, as well as supplier relationship management and performance, and study start-up. Kevin’s career spans operational and strategic roles in multiple start-ups (both tech and pharma) and large biotechs such as Amgen and Gilead. He spent the last 13 years growing and scaling multiple operational functions, developing a global team from 18 to 137 to support two separate companies as they experienced rapid growth.

Angie graduated from the University of Thomas Jefferson with a Bachelor of Science in nursing and over 24 years of experience in pharmacovigilance at Merck. She is the associate vice president of PV operations and global process enablement, and she is accountable for setting standards to enable systems and processes globally to ensure quality and compliance with individual case and aggregate safety reporting.

Matt Studney is vice president of information technology for Merck’s Research Laboratories (MRL) division, where he is accountable for all aspects of information technology from strategy to implementation for discovery, developmental sciences, clinical research, regulatory, pharmacovigilance, real world data, and medical affairs. Matt is currently focused on the frictionless flow and access of data for Merck scientists and simplifying the clinical, regulatory and pharmacovigilance operations. Additionally, he is leading and sponsoring multiple efforts to pilot and scale machine learning, artificial intelligence (AI), and generative AI capabilities. Matt has more than 20 years of experience at Merck, across multiple business areas.

Jenn heads global quality at Moderna and is responsible for the QA and QC organizations. She started with Moderna in June 2017 and has 23 years of experience in quality at pharmaceutical companies. Her industry experience has included GCP, GLP, and GMP quality roles at Intervet, Inc., Stryker Biotech, Olympus Biotech, and Alexion Pharmaceuticals. She has extensive experience leading global health authority inspections, quality system development and improvement, and quality assurance oversight. Her responsibilities span from overseeing manufacturing and testing, commissioning and area start-up, and managing packaging and distribution to supporting the development and commercialization of pharmaceuticals and medical devices. Jenn has a B.S. in biology and a Master’s in biochemistry from the University of Scranton.

Joanne started her career at GSK before moving to Roche and has worked in preclinical, clinical, and regulatory functions. On moving to Roche, she headed up the global labeling function, which gave her a great understanding of the complexities of the business from clinical to supply to the affiliate organization, which led Joanne to her current role as head of regulatory operations and business excellence. Besides her operational responsibilities, she also sponsors the regulatory non-product portfolio programs, including Vault RIM implementation and regulatory digital innovation. She is passionate about people development, driving transformation to reduce complexity and digital innovation.

Brian is a seasoned technology leader with 28 years of experience in pharmaceutical R&D IT. He currently serves as the VP of R&D technology at Takeda, where he drives strategic IT initiatives enabling the discovery and delivery of life-impacting medicines and therapies. Brian has held senior roles at Spark Therapeutics and Johnson & Johnson, where he spent 18 years working in R&D IT across pharmaceutical, consumer package goods, medical devices, and diagnostics. He is also the founder of Olokun Consulting LLC, focusing on addressing healthcare disparities and fostering leadership in the healthcare sector. Brian holds a Ph.D. in Chemistry/Biology from Princeton University, underscoring his expertise and love of science.

With over 20 years of experience, Seb is passionate about leveraging digital technologies in new ways that positively impact patient’s lives.

Avril is the general manager of Veeva Vault, a fast-growing cloud software platform and suite of applications to manage content, data, and business processes for life sciences and other regulated industries. Under Avril’s leadership, Veeva Vault has grown to represent 40% of Veeva’s revenues. Avril has over 20 years of experience building and scaling product teams, including 15 years at innovative software-as-a-service companies. She was a key contributor to two successful IPOs and played leadership roles at world-class organizations, including Oracle’s PeopleSoft, Cisco’s WebEx, and IBM’s DemandTec. Avril holds a bachelor of commerce honors degree from Queen’s University in Ontario, Canada, and has received numerous professional and academic awards.

Before joining Veeva, Christina spent over 15 years in the life sciences as a consultant and business development partner spanning study start-up and TMF management, pharmacovigilance, and regulatory. Currently, Christina is the senior director of Vault Safety strategy, focused on customer feedback on the Vault Safety suite of products. She is an advocate for her customers and ensures Vault Safety is meeting the needs of the industry. Christina has been with Veeva for over five years.

As vice president of Vault Development Cloud at Veeva, Jim leads a global team responsible for customer engagement, market adoption, and strategic alliances. For the last twenty years, Jim has held various senior positions in life sciences technology and consulting, where he has led software delivery and sales efforts in clinical operations, regulatory, clinical data standards, and content management.

Jared is a senior director of strategy at Veeva, working across the Development Cloud applications. In his role, Jared brings together cross-functional application teams to ensure a holistic approach is delivered in strategy, product, and services. Before moving to the strategy team at Veeva, Jared ran a team responsible for scoping and planning application implementations. In addition to his years in life sciences, Jared brings experience from prior consulting roles at Epic delivering electronic medical records systems to hospitals.

John has over 20 years of experience in the pharmaceutical industry. He is currently vice president of Vault Safety. In this role, he’s responsible for growing our safety market success and setting the direction, strategy and growth plans for our suites of applications. He’s been heavily involved on the safety side for more than 18 months. Before joining Veeva, John led the consulting group at Octagon Research Solutions (now Accenture), which specialized in assisting clients with planning and developing CDISC-based data and regulatory submission capabilities to achieve regulatory compliance while maximizing operating efficiencies. He has extensive experience with implementing globally-deployed systems. John has also worked for Computer Sciences Corporation, where he led business analysis, process design, organizational change, and project management activities. John graduated from Bucknell University with a bachelor of science degree in mechanical engineering.

Marc is vice president of Vault RIM at Veeva Systems, responsible for the overall growth and execution of the regulatory product line. Prior to joining Veeva in June 2017, he served as client partner and RIM consulting lead at Kinapse (now Syneos Health). Marc also spent fourteen years in Accenture’s pharmaceutical R&D practice where he led the organization’s regulatory advisory, business development, and alliance efforts. During that tenure he helped half of the world’s Top 20 biopharmaceutical organizations in various consulting and program delivery roles spanning regulatory and pharmacovigilance.

As vice president of quality and manufacturing at Veeva Systems, Mike Jovanis leads the quality solution portfolio, driving product strategy, innovation, partnerships, and cross-functional execution to ensure customer success. He is educated at Rutgers University, and holds a bachelor’s degree in marketing and an MBA in strategy and global business.

Peter Gassner is the visionary behind Veeva, one of the world’s most successful and innovative cloud software companies. He pioneered the industry cloud category when he founded Veeva in 2007 with the belief that vertical cloud software would be the next wave of cloud innovation. Today, Veeva helps more than 1,000 life sciences companies bring new medicines and treatments to patients faster.

With more than 30 years experience at leading technology companies, Peter has been at the forefront of every major transition in enterprise software, from the mainframe at IBM Silicon Valley Lab, to client-server at PeopleSoft, the cloud at Salesforce, and industry cloud software at Veeva. He was a key visionary force behind three of the industry’s most successful enterprise application platforms: Veeva Vault, the Salesforce Platform, and PeopleTools.

Peter currently serves on the board of directors of Veeva and Zoom. He holds a bachelor of science degree in computer science from Oregon State University.

Richard is VP of strategy for Vault CDMS and a 25-year veteran in life sciences. Richard is responsible for defining the strategy and direction for Vault CDMS, especially concerning clinical data management. Richard brings Veeva customers a keen executive vision and proven operational experience in data management, eClinical solutions, and advanced clinical strategies.

Abbey has been on the Vault RIM professional services team for six years, focusing on implementing Vault RIM solutions with expertise in registrations, xEVMPD, and IDMP. As a practice manager, she leads a team of implementation consultants, ensures service delivery excellence, and helps drive internal initiatives. Most recently, she oversaw the development of the Vault Submission Publishing eLearning.

Alessandro is the product manager for Vault RIM Submissions Archive. He joined Veeva in 2021 as a professional services consultant, supporting customers in Vault RIM implementation projects with a concentration in RIM Submissions, RIM Submissions Archive, and RIM Submissions Publishing. Currently, Alessandro is responsible for leading the design and development of RIM Submissions Archive features, which include eCTD 4.0 support, expanded regional DTD or schema support, and overall user-friendliness.

Alexis is a clinical data solution consultant at Veeva, where she is responsible for identifying customer challenges and objectives, demonstrating solutions that address requirements, and bringing business value to the organization. Prior to joining Veeva in 2021, Alexis held various positions at companies focused on patient-centric technology, including Greenphire and, most recently, YPrime as an eCOA product manager. In this role, she worked with clients to identify product needs, managed the product roadmap, and set objectives and priorities. Throughout her many years in the clinical trial space, Alexis has helped over 30 companies kickstart their patient technology initiatives.

Alice is a clinical data solution consultant at Veeva, where she is responsible for identifying and understanding customer needs and goals to propose solutions that improve their workflows and processes. When she joined Veeva in 2018, Alice was a consultant on the CDMS services team, configuring studies for many customers on both the CRO and sponsor sides. This experience has given her expertise in study build best practices within the Vault CDMS product.

Alyssa is RTSM program director at Veeva, bringing a decade of experience in the clinical data sector. Her career spans diverse roles with RTSM and clinical data solution providers, where she has honed her skills in delivering quality RTSM systems. At Veeva, Alyssa ensures that customers and their study teams receive systems that exceed expectations, facilitating smooth execution while fostering strong, lasting partnerships. She plays a crucial role in defining customer standards and creating efficient, unified systems and processes, thereby enhancing overall operational effectiveness.

Ashley has over thirteen years of experience in life sciences technology, including over eight and a half years at Veeva. As senior director, Vault LIMS strategy, Ashley is responsible for go-to-market strategy, customer engagement, and business development for the Vault LIMS application. During her time at Veeva, she has led growth strategy for the quality space across several different products and markets, including supporting the launch of Vault QMS and Veeva’s pursuit in the contract services and generics markets. Before Veeva, she served as industry solution manager in the product management and strategy team at Sparta Systems where she led the pharmaceutical vertical market efforts. Ashley received her bachelor of science degree in biology and music from Boston College and a master’s degree in biotechnology from Columbia University.

Bernat is a solution consultant for Vault Validation Management at Veeva Systems, specializing in the European market. With a solid background as a biomedical engineer, Bernat possesses over seven years of experience in the life sciences industry, working in diverse environments ranging from small-scale startups to large-scale organizations. Leveraging his technical expertise and industry knowledge, Bernat offers a unique perspective on harnessing digital tools to drive the digitalization and efficient management of validation processes.

Billy is a senior solution consultant for clinical operations at Veeva. Over the last 11 years, Billy has worked in various capacities in life sciences and marketing organizations. He found that across all of them, it’s the people who energize him and make the difference in his daily life. He has worked for both large pharma and startups.

With a passion for problem-solving and a deep understanding of site engagement, Bipin is a seasoned solution consultant with over 25 years of experience delivering impactful solutions to customers across the life sciences. He excels at translating complex challenges into innovative and practical solutions within the context of cloud and platform-based clinical solutions.

Bree has held various roles, including a bedside ICU nurse, research coordinator, team manager, and senior director of a large central clinical trials office across three leading academic medical centers in the US. She has been responsible for over 1,000 trials spanning all translational stages across 38 unique clinical departments. Bree has developed and implemented many technical solutions throughout her career to support clinical trial operations. She left Vanderbilt University Medical Center in 2019 to join Veeva where she serves as the VP of strategy for site solutions.

Brian is the product manager for Veeva Vault Batch Release. He has spent over 20 years building various enterprise SaaS solutions and more recently worked for a food coating company, where he was responsible for software and data solutions used to inform customers about the shelf life of produce treated with their shelf-life extension solutions.

Carl is responsible for strategy for Veeva Vault QMS application. With over 25 years of experience delivering transformative solutions in the life sciences, consumer products, discrete manufacturing, and financial services industries, Carl has dedicated over 20 of those years to quality management. He has been involved in over 150 quality/regulatory system design and implementation initiatives and continually seeks ways to innovate quality solutions to help meet business and regulatory requirements and ensure patient safety while maximizing the value delivered for his clients.

Christina has over a decade of experience in regulatory affairs with a focus on operations and product portfolio management. She has worked across both large and small system implementations to solve data challenges and practical user support needs faced in the pharmaceutical industry. In her current role she continues to navigate the challenges across life sciences by overseeing project teams who leverage Vault RIM to bring valuable process understanding and systems functionality.

Dana is a solution consultant, focusing on the Vault Clinical Operations Platform offerings. Before joining Veeva, she worked as a CRA within various CROs, monitoring and managing sites for a variety of indications and phases of studies. Leveraging that experience, she identifies and relates to the business needs of customers and suggests optimal solutions along with providing product demonstrations.

Dylan is a solution consultant at Veeva with the goal of using technology to make clinical research more efficient. In his day to day, he meets with Veeva customers to understand their business and to show how Veeva’s solutions can add value. He’s worked in the life sciences industry in varying capacities. Starting at large research sites, he was a user of many different software products. After moving into the technology space, he’s sold, implemented, and maintained cloud-based systems. Dylan knows the challenges of the industry and is committed to building great software for all the life science stakeholders.

Eric leads the Veeva North American team of solution consultants for Clinical Data. With over 25 years of experience in the industry, he has specialized in data management and the adoption of innovative technology to advance clinical research.

Frank focuses on clinical technology for smaller to scaling companies—addressing the people and processes, adoption challenges, and best practices. He finds it exciting to support the science of his customers and to interact so broadly with the life science industry!

With a proven track record in implementation and post-implementation excellence, Frankie Dharam is passionate about helping organizations optimize their software investments. As the Practice Director of Managed Services, Frankie leads a team dedicated to delivering exceptional support and driving continuous improvement. With a focus on maturing business practices and maximizing software utilization, we are committed to helping clients achieve their full potential.

Harshad is an innovative product leader in the life sciences industry with over 11 years of comprehensive experience in successfully rolling out products and services. He possesses a quality-driven mindset and a track record of excellence in use case identification, result conceptualization, design, testing, and marketing. Recognized as a results-driven change agent, Harshad is committed to fostering trusting collaborative relationships with stakeholders and cross-functional teams. He is dedicated to leveraging his proven skills and expertise to lead successful consulting and pre-sales practices, delivering cutting-edge solutions that drive impactful outcomes.

Heather is an experienced professional services manager with 17 years in the life sciences industry. Specializing in quality, Heather has successfully managed and participated in Vault implementations, from harmonizing business processes across the enterprise to leveraging Vault to create efficiencies and ensure compliance with regulatory agencies. Currently, Heather leads the enterprise quality team, which focuses on delivering exceptional service to pharmaceutical companies globally.

Jason is a product manager passionate about helping customers meet their educational goals through technology. His focus is helping customers while defining and executing the product roadmap for Vault Training. Prior to coming to Veeva, he worked for 18 years in the education industry as a developer, administrator, and product manager of Learning Management Systems.

Jennifer has worked in the pharmaceutical industry for six years, starting as an internal training and development specialist within service operations at Parexel. She transitioned from the education sector, where she was a secondary school biology teacher. At Parexel/Calyx, Jennifer became the strategy lead for training and education within service operations before moving to client knowledge, where she focused on the development of client-facing training and resources. She joined Veeva as a solution consultant in June 2023 and is loving the role!

Jessica has been with Veeva for almost seven years, and she is currently a senior product expert for QualityDocs and Station Manager. She began her career in life sciences over 20 years ago, helping to implement ERP systems in Pfizer manufacturing sites around the world. Jessica has always remained in the quality & manufacturing space and has held various senior consultant, business analyst, and product manager roles at companies including Teva Pharmaceuticals, Accenture, FCG/CSC, Sparta Systems, and OpenText.

Joby leads the product management team for Vault LIMS. Joby has over ten years of experience designing and delivering enterprise quality and training solutions for the life sciences market.

Joe brings 17 years of experience in the clinical research/contract research organization (CRO) industry, collaborating with biotech and pharma companies worldwide. Currently a solution consultant at Veeva, Joe specializes in the full clinical operations suite. He is dedicated to understanding client needs, providing tailored solutions, and ensuring smooth transitions to our services team for seamless implementation. Joseph is committed to delivering effective, customized solutions and building lasting relationships, ensuring an excellent experience for our customers.

John is a senior product manager at Veeva based in Europe working in the RIM product management team. He is focused on delivering new Product Connection from RIM to each product family. Before switching to the RIM product management team, he was a product manager in the Vault API & Tools team for four years, providing direction and hands-on support to partners, customers, and project teams on third-party integrations with the Vault Platform. John has a strong background in implementation, systems integration, and development, following over 20 years of experience in IT working across a number of market sectors.

As a senior solution consultant for Veeva RTSM, Jonathan combines technical expertise with strategic vision to address customers’ needs and challenges related to randomization and trial supply management. Jonathan has over 15 years of experience with clinical information systems. He spent six years implementing electronic medical records in operating rooms and intensive care units before transitioning to the randomization and trial supply management industry, where he has worked for the past nine years.

Jordan is a Veeva product manager on the Submission Publishing team, with extensive experience in eCTD and Non-eCTD publishing capabilities within Vault across regions worldwide. Jordan is responsible for feature design and development within Submissions Publishing.

During Joe’s 19-year career in the pharmaceutical industry, he has dedicated his efforts to assisting customers with all aspects of the R&D drug development process. After graduating from La Salle University, he began his career in regulatory operations. From there, Joe transitioned into consulting and technology implementation, working on solutions that span research, clinical development and data, regulatory information, and safety. At Veeva, he focuses on helping customers maximize the value of Vault RIM to increase efficiency and guiding them on their organization’s path toward regulatory excellence.

Kelsey is a solution consultant with over ten years of experience in the clinical research industry. Specializing in clinical operations, Kelsey collaborates with current and prospective customers to understand their processes and provide solutions leveraging Veeva’s clinical applications.

Kent has been leading Veeva’s portfolio of training products for over six years. He joined Veeva specifically to help solve a long-standing industry gap — the development of life sciences specific learning solutions. Prior to his time at Veeva, Kent spent the majority of his career delivering technology-enabled training solutions to life sciences, holding leadership positions at industry leading companies such as AdMed, ClearPoint (Red Nucleus), UL EduNeering (UL), and now Veeva Systems.

Kevin is a lifelong consultant with over ten years in the R&D pharma space supporting customers with business and technology transformation. Kevin leads the clinical practice within the North America business consulting team with a focus on helping Veeva customers get the most business value and use of the Vault Platform.

Kristina has over 15 years of experience advising and working in the pharmaceutical and biotechnology industries and clinical research. She has led numerous drug development programs, strategically positioning each drug candidate, including Orphan Drug Designations from the FDA, EMEA, PMDA, and NMPA, as well as FDA Fast Track and Special Protocol Assessment designation. Kristina has been leading the RIM business consulting practice in North America, providing delivery excellence and thought leadership across Veeva best practices and business processes, as well as value realization OCM & training. Kristina is a graduate of the University of Michigan and Columbia University.

Laycee is a member of the East American Vault Quality solution consultant team, providing pre-sales support for the Vault Quality Suite. With a background in the industry, Laycee brings previous expertise and technical knowledge to solution options spanning QualityDocs, Vault Training, and QMS applications within Vault Quality.

Lena is a director of RIM strategy at Veeva. With over 25 years of experience working with life sciences industry customers, she has led software and business process development initiatives. Lena holds an MD in pediatrics from the Medical School of Belarusian State University. She is passionate about helping the life sciences industry advance through technological innovation to improve patient outcomes.

Mary Anne is an industry-seasoned Veevan bringing manufacturing operations and first-hand regulatory operations & publishing experience to the RIM product team as a senior product expert.

Matt is a product manager for clinical operations, focusing on connecting Vaults and transferring data. He oversees powerful cross-Vault features, including TMF Transfer, CTMS Transfer, the Quality-ClinOps Connection, and the Safety-ClinOps Connection.

Mike is the strategy lead for Vault Batch Release, focused on developing solutions that automate and streamline batch release processes. He collaborates with customers to ensure Vault Batch Release can transform traditional paper-based systems into digital workflows, significantly enhancing operational visibility and ensuring confidence in market shipment decisions. Mike has recently joined Veeva with 15 years of life sciences experience in the quality space.

Mollie is a senior solution consultant who helps life sciences customers achieve their business goals by understanding and aligning their needs with one or more solutions within the Veeva Clinical Platform. Her professional background is rooted in healthcare IT/SaaS-focused industries, where she has served in roles that encompass various aspects of the client experience—from sales to training to customer success. After spending several years in the on-demand urgent care space before transitioning to pharma technology, Mollie’s continued professional objective is to support clients in their use of technology.

Oliver is a solution consultant for Veeva since 2020. He graduated from university with a degree in biomedical sciences, during which he spent a year working with a Veeva customer. Oliver has a passion for understanding and improving patient outcomes in healthcare.

Pam is a practice manager in Veeva’s professional services group, responsible for leading the implementation of Vault RIM solutions for small and medium sized customers. Pam joined Veeva in 2016 and has over 23 years experience in technology and process consulting in the life sciences industry.

Paola leads the US biotech, CRO, and animal health sectors in quality strategy. She provides thought leadership on embracing technology and modernizing quality to create more efficient and compliant programs.

Paul is responsible for Vault Regulatory strategy and team in Europe. His primary focus is on growing the European market in regulatory. Paul’s background is in software engineering, and for the last 33 years, he has been doing this in the life sciences space.

Rob is a solution consultant for the clinical operations team and specializes in giving pre-sales demos of all Vault Clinical Operations products.

Robin serves as the senior manager of strategy for Vault Validation Management, where she spearheads the advancement and implementation of digital validation solutions for life science companies ranging from emerging startups to global enterprises. Drawing on her engineering background and her hands-on experience as a CSV engineer in traditional paper-based environments, Robin excels at bridging the gap and facilitating the transition to digital validation processes. Prior to focusing on Vault Validation Management, Robin was a quality strategist, guiding companies in establishing their core quality frameworks for document, training, and quality event management. Her expertise in the broader quality ecosystem and traditional validation processes uniquely positions her to drive innovation and efficiency in the validation landscape.

Ruben is a senior solutions consultant with extensive expertise in traditional validation processes and FDA audit defense within the life sciences sector. Ruben then transitioned to consulting, implementing, and managing quality management systems for organizations ranging from emerging startups to global enterprises. Currently, Ruben is dedicated to helping organizations transform their siloed, paper-based validation workflows into streamlined digital solutions with Veeva Vault Validation Management, thereby enhancing compliance and operational efficiency.

Since joining Veeva nine years ago, Ryan has been working as a cross-functional member of Veeva’s services organization, working across many different products and areas on the Vault Platform. Currently, Ryan leads Veeva’s Enterprise Application Management (EAM) services team, which provides operational support and continuous improvement services for Global customers. Ryan’s current areas of focus are Release Management on the Vault Platform, Vault Sandboxes, and DevOps for Veeva Vault.

Rylan leads Veeva’s R&D business consulting team for North America. This team’s mission is to help Veeva’s customers realize the full value of Dev Cloud, and use its capabilities as a catalyst for R&D operating model transformation. Rylan lives in northern New Jersey. Prior to Veeva he worked at the Boston Consulting Group. He’s a US Navy Veteran, with degrees from University of Pennsylvania and Duke University.

Samantha has a decade of experience in life science technology including over four years at Veeva. As a director of quality strategy at Veeva she focuses across the quality application suite. She is passionate about helping organizations optimize their quality software footprint. Before moving to the strategy team at Veeva, Samantha ran a team responsible for scoping and planning transformational programs.

With over 16 years in the pharmaceutical services industry and over 25 years of software development experience, Shad has a strong foundation for delivering real value to Veeva’s clients and partners. Shad currently leads Veeva’s global strategy for Vault Study Training.

Shanul is the manager of the North American quality solution consulting team at Veeva, leading a team of solution consultants dedicated to showcasing Vault Quality applications, including Quality Docs, QMS, Vault Training, and LIMS, to life sciences companies across North America. Since joining Veeva in 2019, Shanul has held key roles, starting as a product manager on Vault Safety before transitioning to the quality solution consulting team in 2021. Prior to Veeva, Shanul was a product manager at Ontario Telemedicine Network (Now Ontario Health), responsible for the OTNhub telemedicine platform.

Silpa is a part of the clinical strategy team, focusing on the SMB CTMS market & supporting Vault Clinical Operations (eTMF, CTMS, Study Training, Payments, SSU and Site Connect).

Tj joined Veeva in 2019 and has spent the vast majority of his time at Veeva working with our Vault Publishing customers. His 20+ years of experience in the pharma industry has spanned biopharmaceutical manufacturing, quality, and regulatory operations. After two years as a practice manager delivering publishing to new customers, Tj is now focused on our publishing implementation methodology working with product and services as the global domain lead for Vault Publishing.

Vicky is part of the Vault Platform Product team, where she is responsible for the Vault Mobile app and other features like Print Record. Prior to Veeva, she worked at a health technology startup building mobile products ranging from health education to cancer survivor support.

Walid is a senior product manager for Vault Platform Workflows and has been at Veeva for almost four years.

Amy is a highly experienced nurse with a BSN degree. Her passion for patient safety led her to pharmacovigilance in 2006 at Hospira Inc. She joined Abbott/Abbvie in 2010, where she excelled in ICSR processing and became an expert in outsourcing PV activities. In 2019, Amy was selected as the business lead for Veeva Vault Safety’s implementation, completing the project in a record-breaking 14 months. Today, she is an associate director of innovation and technology, leading the SafetyDocs strategy. She is also part of AbbVie’s “Innovation Swat Team,” solving technology and process-related challenges for stakeholders. Amy aspires to be a true innovator in the field of pharmacovigilance.

Lorena has over 25 years of experience in clinical operations and is currently the head of global business operations at AbbVie. She joined Abbott (which became AbbVie) in 2008 as a senior clinical operations manager and went on to hold leadership positions in clinical site management, clinical study leadership, global study start-up, and COA management before taking her current role. Lorena holds a BS in microbiology, a BA in molecular biology, and was an NIH fellow in the University of Texas at Austin Pharmaceutics PhD program.

Allison graduated from Washington University in St. Louis with a B.S. in Biomedical Engineering and B.A. in International and Area Studies. Since graduating she has worked for Accenture, in the Life Sciences R&D practice, with a focus on driving Clinical and Regulatory technology transformations for major global pharmaceutical organizations. She is interested in helping organizations achieve process and operational improvements by optimizing their use of enabling technologies.

Jamie is a distinguished leader in the field of data management with over 20 years of specialized experience. As the head of eClinical programming and solutions at ACELYRIN, Jamie strives for consistency in eCRF design, standards, and eClinical technologies. Her extensive career is marked by a commitment to excellence for enhancing data management practices. Jamie’s current focus is on standardizing database builds and data flow processes, optimizing data review mechanisms, and advancing the use of data analytics and visualization tools to tell the data story. Her strategic vision and expertise are pivotal in driving efficiency and innovation within the eClinical domain and beyond.

Jinit is an energetic, innovative, passionate, collaborative, and pragmatic leader. He is a problem-solver with a record of creating solutions and strategies to maximize business efficiencies and promotes compliance through implementing high-quality, fit-for-purpose, appropriately risk-based systems and solutions. Jinit has effective upward and downward influencing capabilities for establishing and adopting creative processes and improvements without compromising quality or compliance. He is enthusiastic about leading and developing by inspiring teams and stimulating success.

Brandy is the quiet force behind Alcon’s clinical systems and standards. Her knack for implementing comprehensive platform solutions like the Veeva Clinical Suite has established her as the go-to expert in her domain. Brandy’s unassuming nature belies her incredible talent for turning complex challenges into simple, elegant and best-in-class outcomes. Her team adores her, not just for her expertise, but for the genuine care she brings to every interaction. Brandy’s leadership is the kind that inspires without fanfare, making her an indispensable asset to everyone she works with.

Over her 17-year career in clinical trials, Leianne has held leadership roles in standards, clinical systems, and data operations at Alcon and Novartis. Currently, she is the head of global data operations at Alcon. Leianne is highly experienced in managing large cross-functional projects and change management initiatives. She holds a bachelor of applied science and a graduate certificate in statistics from Texas A&M University. Earlier this year, Leianne was recognized as a Veeva Hero for her work to improve clinical data management at Alcon.

Todd is an IT professional with 29 years of experience, including 20 years at Alcon, a global leader in eye care. He specializes in implementing and supporting enterprise applications and integrations across ERP, manufacturing, distribution, and R&D systems. Currently, his Veeva DevOps team manages an ecosystem of 6 Vaults hosting over 18 Veeva applications.

With over 20 years of experience, Desmond is a global operations leader with a distinguished career in biotechnology and pharmaceuticals, specializing in operations for cell and gene therapy. With a strategic oversight that drives innovation, as the vice president, head of global operations: cell and gene therapy, he is responsible for creating and implementing a strategy for CGT in collaboration with leaders across Allucent.

In her two-decade career, Heidi has established herself as a versatile pharmaceutical informatics and quality management leader. As director of Alvotech’s Vault Platform, she oversees critical IT functions encompassing Vault Quality, RIM, Clinical, and LIMS. With a strong focus on ensuring seamless Veeva solutions delivery and continuous improvement, Heidi collaborates closely with business partners and effectively manages vendor relationships. Her expertise includes project delivery, risk management, and optimizing electronic management systems. She has a proven track record of driving operational efficiency and compliance across global teams, marked by achievements in system implementation and strategic IT governance.

Jim has over 25 years of experience in the biotech and pharma industry, with 20 of those working for Amgen. His background is in software and computerized systems quality, and he has recently managed the corporate quality systems department.

Maggie has over 25 years of experience in the biotechnology industry, with a focus on computer system implementation and operational excellence. She has been a senior business analyst and quality assurance (QA) leader at Amgen since 1995. She has played key roles in research and development and good manufacturing practice (GMP) computer systems, managing the full lifecycle of global systems across the digital landscape. In a recent partnership with the Digital Technology & Innovation (DTI) team, Maggie developed and released a Risk-Based Validation process using Computer Software Assurance (CSA) guidance. This strategic initiative will advance Amgen’s digital capabilities and create competitive advantages in the industry.

Sudhir is an accomplished information technology professional with two decades of diverse experience managing various programs within the biotech and pharma industries. He has proven expertise in computer system validation (CSV), transaction-to-computer system assurance (CSA), audits, IT controls, compliance, business process improvement, agility, program management, and delivery. Currently, he is leading the transition from CSV to CSA for the QMS implementation, overseeing the enterprise risk-based validation implementation, and ensuring compliance with industry regulations.

Thomas has over 25 years of experience in the medical device and biotechnology industries, focusing on computer system implementation and operational excellence. As a quality assurance (QA) leader at Amgen in the GxP computerized system and validation, he has been instrumental in managing the full lifecycle of global systems across the digital landscape, from software supplier evaluations, validation/test, maintenance and decommission activities. In a recent partnership with the Digital Technology & Innovation (DTI) team, Thomas helped to develop and release a risk-based validation process using computer software assurance (CSA) guidance. This strategic initiative will advance Amgen’s digital capabilities and create competitive advantages in the industry.

With over 15 years of experience implementing R&D business processes and cross-functional technology, Sumit is a passionate and skilled leader who strives to deliver high-quality and reliable regulatory data to clients across the life sciences industry. As the head of regulatory information management (RIM) at Apellis Pharmaceuticals, he leads a team of RIM professionals who use industry-leading RIM technology to manage their regulatory information. Their expertise spans managing regulatory data, business process development, technology implementation, data governance, and maintaining data integrity throughout the product lifecycle. He is committed to collaborating with crucial RIM stakeholders and innovating to build best-in-class RIM organizations that comply with global regulatory requirements and standards.

Kelly has 20 years of experience supporting life sciences organizations in implementing and adopting regulatory systems. She has built and led global RIM teams across sponsor and CRO companies while driving growth and innovation for regulatory affairs and operations. Kelly is currently the senior director of RIM and systems at Arcus Biosciences, directly responsible for data governance, data quality, integrations, reporting, and technology strategy. Kelly is proven to drive regulatory change at the intersection of business and technology, from pre-market through NDA stages of global development.

Dr. David Carruthers is an established leader in Clinical Development and Operations with over 20 years of experience in Drug Development. Dr. Carruthers has led cross-functional teams across the US, Europe, and Asia, driving organizational transformation and research innovation. Currently, as Vice President of Clinical Operations, Clinical Data & Insights at AstraZeneca, Dr. Carruthers leads a global team responsible for clinical data, insights, and analytics across early and late portfolios for both BioPharmaceuticals and Oncology R&D.

Goutham is the associate director of regulatory publishing. With a decade of experience in the field, he specializes in regulatory affairs, regulatory intelligence, and regulatory publishing. Throughout his career, Goutham has achieved numerous milestones, including successful regulatory submissions to various health authorities, which have significantly expedited the delivery of medicines to patients. He has also led the implementation of publishing systems across enterprises and spearheaded the transition from paper to electronic submissions, showcasing his expertise and leadership in regulatory publishing.

Meg, vice president of global clinical data management, has over 28 years of experience within the life sciences industry managing global teams across data management and multi-functional FSPs. Meg specializes in partnering with clients to create a tailored and strategic approach to their outsourcing strategies while fostering a team environment. This collaborative methodology optimizes partnering initiatives producing successful data driven outcomes. Meg is a 4-time SCDM presenter and previous Veeva Summit panelist. She has received awards for Talent Management (employee development) and FSP Executive Excellence.

Peter, head of AI and automation at BASE, is a nerd with a passion for transforming business processes. For nearly six years, Peter has been instrumental in developing and implementing cutting-edge solutions for the pharmaceutical industry. Presently, the focus is on the BASE AI Assistant for Veeva Vault, which showcases how artificial intelligence can enhance efficiency and accuracy in regulatory operations.

Ellen has 20 years of experience in the pharmaceutical industry. She started in her local community as a monitor and has held various positions in global clinical trial management since 2009. Over the last five years, she has established a team to support a study-specific training strategy that includes setting the vision and technology for a multi-method and customer-oriented approach to support the successful conduct of clinical trials. Ellen currently leads the implementation of Veeva Vault Study Training at Bayer.

Emma has over 20 years of experience in the pharmaceutical industry. She started as a monitor and has held various positions in clinical development operations. During that time, Emma worked on multiple systems and process implementation projects. She heads a team of business solution managers responsible for implementing, maintaining, and supporting key systems utilized by clinical development operations, including Veeva Vault Clinical and Vault Study Training. In 2021, Emma received the Veeva Hero Award for her work to eliminate system siloes at Bayer.

Mandy is a regulatory and IT operations professional at BeiGene with over 20 years of experience. She excels in managing high-performing matrix teams and streamlining processes through innovative solutions, often with a touch of humor. Mandy is an expert in RIM system implementations and regulatory operations, including eCTD publishing, data quality and governance, XEVMPD, IDMP, and SPOR. Her leadership in regulatory data integrity programs and commitment to team development have earned her respect across the industry. She holds an MS in regulatory affairs and quality assurance from Temple University and a BS in business information systems management from The College of New Jersey.

BJ got his start in pharma teaching users how to use Word templates and toolbars to write documents for eCTD submissions. He still loves training people on Word. Eventually, he worked his way up to being a submission publisher. He’s published three NDAs, two MAAs, and more INDs than he can count.

Jamison is a well-rounded and dedicated leader with close to two decades of experience managing phase I-III clinical trials, including on-site/in-house clinical monitoring, data management leadership, and Veeva Vault Clinical system administration. He has overseen successful implementation of Veeva eTMF and CTMS vaults within BioCryst.

Mohith is a senior pharmaceutical technology leader with over 15 years of experience leading global technology programs across clinical, regulatory, and quality areas. At BioNTech, he is responsible for leading the Veeva Competency including the platform governance and service management of Veeva platforms.

Joe oversees the digital strategy and governance and global quality function at Bristol-Myers Squibb. He has over 24 years of industry experience, and before joining BMS, he worked at Teva Pharmaceuticals, Merck, and Schering-Plough. Joe has extensive experience in compliance, data integrity, data quality, computer systems validation, quality systems development and deployment, change management, and documentation. He holds a Master’s Degree in Business Administration in Management Technology and a Bachelor’s of Science in Management Information Systems from New Jersey Institute of Technology, Newark, NJ.

Grace leads global quality operations at Cerevel Therapeutics where she is responsible for the administration and management of quality technology solutions. She is also involved in a variety of other quality activities, including managing the company-wide training program, overseeing the deviation and CAPA processes, auditing vendors and clinical sites, and supporting inspection readiness activities. Grace is certified in healthcare research compliance (CHRC). Prior to joining Cerevel, she received her J.D. in health and biomedical law from Suffolk Law School in Boston, MA.

Dee is the head of global regulatory operations at Cerevel Therapeutics. With over twenty years of experience, she has overseen the successful submission of marketing applications globally and built the reg-ops function from the ground up at Cerevel and Synageva. She is an expert in regulatory systems and related business process development. Before launching Vault RIM at Cerevel, Dee led the successful change management program to implement Vault RIM at Vertex. Dee has a degree in biotechnology science from Northeastern University, has obtained the RAC Certification in regulatory affairs, and is Veeva Vault Platform certified.

John has spent the last 25 years in global clinical research, specializing in the development of novel oncolytic therapies. He has lead global clinical operations, from clinical study design to submission of final study report including BLA filing. John has expertise in strategy development, risk management, project planning and execution, and consistently achieving program goals. With a Six Sigma Green Belt, he specializes in identifying key areas to find efficiency in clinical study conduct to save time and reduce cost. John previously held leadership and management positions at SillaJen, Inc, Janssen, Inc, and Amgen. He is a graduate of Hampton University with an BS in biology and has a Masters in health administration from the University of North Carolina, Chapel Hill.

Janki is a board-certified infectious disease physician with a keen interest in drug safety. She has spent the last several years as the global safety lead for CRISPR therapeutics immuno-oncology, in-vivo, and auto-immune programs.

Rabiah is a pharmacovigilance professional with over nine years of industry experience across various therapeutic areas, including immuno-oncology, cardiovascular, and auto-immune. Her primary function is in PV operations, but she also supports compliance, medical, and reporting.

Sepideh is a PV physician with over 20 years of experience in the pharma and biotech industry. She covers patient safety and pharmacovigilance in different therapeutic areas, focusing on establishing pharmacovigilance operation and risk management/ safety oversight framework. She is the head of global pharmacovigilance and risk management at CRISPR Therapeutics.

Pontaah is an experienced leader who drives global quality training and documentation systems and oversees enterprise-wide harmonization and transformation. She successfully implemented Veeva QMS and QualityDocs, enhancing operational efficiency and user engagement. Pontaah develops comprehensive, innovative training strategies with robust KPIs and streamlined onboarding processes. Through close collaboration with key IT and business partners, she will begin implementing Vault Training this year. She fosters cross-functional partnerships to optimize organizational performance while sharing best practices across CSL Behring.

Rynita is the director of information technology at CSL Behring, leading global efforts in developing medicines for rare and serious diseases. A strategic, results-driven leader, she excels in planning, systems implementation, business development, and change management. Most recently, she has been responsible for developing and managing a multi-year, integrated program plan to implement Veeva’s platform across the CSL group. She is also responsible for implementing ongoing life cycle management for the Veeva platform, including releases and strategic platform expansions. She holds an MBA from Elon University and chairs the MBA Board of Advisors.

Brittany is a quality professional in the biopharmaceutical industry. She has spent 12 years working in gene therapy and gene editing. Her primary focus has been on document control, training management, and quality systems. Before her life in biotech, Brittany worked as a librarian.

As a director of trial capabilities at Eli Lilly and Co., Angela oversees the strategy and management of clinical trial study startup, while also leading the development of innovative system solutions for business needs. She has worked in different Lilly laboratory roles for eight years before moving to study startup, where she has almost 17 years of experience and over 7 years in clinical system development. She has a bachelor’s degree in biology from Indiana University.

Laura has 24 years of experience in the pharmaceutical industry. She has spent the last six years in global regulatory affairs on the business technology and process team, working on the end-to-end implementation of Veeva Vault RIM. She has recently taken the position of RIM system and data quality owner.

Liza started her career at Eli Lilly and Co., working as a study manager. She then transitioned to quality management systems, working to maintain Lilly’s medical standards and procedures, where she was responsible for their TMF procedure. This allowed her to move into the systems group, supporting the initial set up, implementation, and roll out of Vault eTMF. She is currently serving as the SSU product owner and was responsible for the set up and implementation and continued support.

Ryan is the director of quality management at Forge Biologics. He brings over a decade of quality experience within the pharmaceutical industry and six years specifically in the cell and gene therapy sector. Since joining Forge in November 2020, Ryan has been pivotal in developing and implementing quality management systems to support clinical manufacturing for Forge’s clients. His extensive background includes significant experience supporting clients in the CDMO landscape, ensuring the highest quality and compliance standards.

Abita is a digital transformation expert who drives operational agility and sustains outcomes in leading global pharmaceutical organizations. Her prior experience spans quality, safety, and regulatory. She also worked as an FDA inspector early in her career.

Steve is the founder and managing partner of Gens & Associates, a life science benchmarking and advisory firm specializing in regulatory benchmarking, performance improvement, regulatory information management, and organizational transition. He started his career at Johnson and Johnson and then transitioned to consulting, where he led global life science consulting practices for First Consulting Group and Booz Allen Hamilton. Steve has a Bachelor of Science in business computer science and a Master’s in organizational development.

Amit is a visionary IT leader with an excellent balance of technology and management and 20+ years of corporate experience designing and delivering technology solutions. As a senior director of IT enterprise platforms, Amit leads a global technology team and is responsible for Vault Platform COE strategy and execution within Gilead. Most recently, his team has contributed to the worldwide implementation and expansion of Vault Quality and Vault RIM solutions with integrations and automation into SAP ERP solutions at Gilead Sciences.

Arshad is the head of global data management at GSK. He is a physician by training and brings over 20 years of experience in the health sciences industry. Prior to the current role, Arshad held a variety of positions in life sciences including consulting, software product management, clinical data management, business development, and electronic clinical outcomes assessments. He has managed clinical data management teams across all phases of clinical development. Arshad is a Board of Trustee of the Society for Clinical Data Management and an alumnus of Armed Forces Medical College, Pune and Indian Institute of Management, Ahmedabad.

With a bachelor’s degree in nursing and practicing as a registered nurse, Jo started a career in pharma as a data manager. Spent over twenty-seven years managing multiple therapeutic areas, developed and mentored staff on clinical trials, and gained expertise in oncology data management. Over those years all spent in clinical data management in various roles, led the successful implementation of several innovative and strategic process improvements.

With over two decades of industry experience, Sean has been at the forefront of building cutting-edge global regulatory operations teams. His track record includes securing numerous product approvals and providing critical support for global expansion initiatives at smaller companies. Now, as the vice president of global regulatory operations at GSK, Sean leverages his extensive background in regulatory affairs and technology to drive continued success on a global scale within a larger organization. Sean’s expertise spans various aspects of investigational and marketed medicinal products, including drugs, biologics, and medical devices. Additionally, he has played a pivotal role in developing innovative technology solutions that significantly accelerate submission timelines. Sean’s journey exemplifies the fusion of regulatory expertise and technological innovation in the dynamic landscape of global healthcare.

Cibele serves as the global director of single-case processing at Haleon, overseeing end-to-end case processing worldwide. Her responsibilities encompass literature surveillance, safety database oversight, data privacy, and vendor management. She played a crucial role in the development and implementation of Veeva Vault Safety from a business perspective, including business readiness activities, development, and implementation policies and procedures. With 15 years of pharmacovigilance experience at multinational companies, she brings a wealth of expertise to her role. Cibele is also a physician with a PhD in obstetrics and gynecology.

Michael started his IT career in a combined level 1-3 helpdesk role, where he taught himself about servers, networks, and enterprise systems. He progressed into roles in application support, project management, service, architecture, business partnering, and product management. During his time at GSK and Haleon, Michael partnered with the clinical, medical, toxicology, and regulatory teams before his current role in consumer safety. This has led to his involvement in selecting and building four of the five Veeva Vaults used in Haleon’s R&D division. Based in New Jersey, Michael has been with the combined GSK and Haleon companies for 24 years.

Monica is a seasoned program manager with 25 years of experience in pharmaceutical research and development. She has worked in clinical trial management, data science, system development and deployment, user engagement, and various other aspects of R&D. She joined the consumer healthcare world at Haleon two years ago and has been supporting clinical development, medical affairs, and pharmacovigilance. Most recently, she helped lead the Haleon Veeva Safety Vault project to a successful deployment in April 2024.

Paula is a successful, clinically licensed executive with extensive, diverse experience and accomplishments across the spectrum of the healthcare delivery system. She is the business administrator for Veeva Clinical CTMS, eTMF and payments implementation, CDMS implementation, and randomization.

Camille has over 20 years of experience as a quality professional in large and emerging pharmaceutical companies at all product lifecycle stages. Camille spent 16 years transforming paper quality processes into electronic systems, transitioning divested quality records out of electronic systems, and integrating electronic systems from several companies. Camille is passionate about keeping systems simple, flexible, and connected to enhance the user experience and meet ever-changing business and compliance needs.

Jenni has worked in the validation world for over 15 years. She has extensive experience in various validation fields, from equipment qualification to process validation to her most recent take on CSV. As her role involves working closely with her quality counterparts, she further expanded her career and got her MSQA. Jenni now has the best of both worlds—validation and quality.

Bonne joined Inhibrx Biosciences, Inc. as the vice president of operations. She has extensive experience in both early and late-stage oncology studies of small molecules and biologics as well as non-oncology programs in allergy and pulmonary disease. Prior to joining Inhibrx, Bonne served as the chief operating officer for Tracon Pharmaceuticals and has held management positions in clinical operations at Pfizer, Biogen Idec, and IQVIA. She was responsible for setting up in-house operations and systems for Inhibrx and Tracon including Veeva Clinical, CTMS, eTMF, Payments, Safety, Quality and RIM. Bonne received a B.A. in kinesiology and biology from the University of Colorado, and an M.B.A. in technology management from The University of Phoenix.

Teryn has been in the biopharma industry for eight years, focused on TMF management and clinical business systems management for the past five. She recently led a back-room team through a successful FDA inspection with no 483 findings. She has an interest in leveraging her passion, knowledge, and expertise in these areas to teach other colleagues and functions the importance of the TMF and how their area of expertise contributes toward maintaining a complete and inspection ready TMF.

Arlette is an agile, adaptable, and accomplished biotech professional. She has over 16 years of industry experience across several operational roles, multiple therapeutic areas, and clinical trial phases in combination with 18 years outpatient oncology site experience. Arelette has a targeted interest in operational excellence and process improvement.

Carolyn has worked in the biotech space for over ten years, using Veeva for nearly as long! In her current role, she is the business system owner at Kura Oncology for Veeva eTMF, and in that capacity she works with study teams to maintain metrics and perform trend analyses for study documentation where her partner CROs upload and QC documentation.

Scott is the editorial director of Lab Manager Magazine. He spent 30 years as a research chemist, lab manager, and business leader at Air Products and Intertek. He earned a BS in chemistry from Michigan State University and a PhD in physical chemistry from the University of Wisconsin-Madison. Scott is an active member of ACS, ASMS, and ALMA.

Wilesha is a game-changer, leader, mentor, educator, innovator, and team builder. She is a quality-driven, positive, and proficient regulatory affairs professional with over 15 years of experience in project leadership and submissions publishing. Wilesha began her career in 2006 at GSK as a publishing assistant and completed her tenure there as a CMC submission specialist. Her journey continued as she ventured into the intricate CRO world and made her mark at Quintiles/IQVIA as a regulatory affairs officer then and PPD as a regulatory affairs manager. Wilesha currently serves as the associate director of regulatory operations at MacroGenics.

Ali is the product line lead responsible for the strategic digitization of Merck’s quality operational systems. She is an experienced leader at the intersection of technology and quality. Ali has spent almost 20 years focusing on laboratory, manufacturing, and quality management systems, strongly focusing on innovation, controls, and computer systems assurance. Before joining Merck, Ali was with Pfizer, where she led innovation and digital audit, including the Veeva QMS implementation efforts across enterprise audit, deviation, and document change control processes. She also held roles of increasing responsibility at PwC and Johnson & Johnson.

Carol has worked in life sciences for more than 25 years. She has supported technical operations, quality assurance, and, most recently, digital / IT.

Erin has over 20 years of clinical research experience across all phases of vaccine clinical development at Merck, including as a key contributor to the development and licensure of Gardasil®9. Erin has led and sponsored several key initiatives, including a vaccine reactogenicity project to implement new regulatory standards for safety data collection, and is currently fully dedicated to the Zero Gravity transformational project. The goal is to modernize Merck’s clinical development systems, creating more efficient processes and ways of working. Erin is passionate about developing talent and building strong, inclusive teams. She holds a Bachelor of Science in Biology from Lehigh University and a Master of Public Health from Drexel University. Erin is a certified project management professional.

Jennifer has over 25 years of clinical trial experience starting as a clinical research associate and progressing to leadership roles in clinical operations, data management, and clinical supply functions. She joined Merck as head of North America country operations, and is currently vice president, clinical trial data, quality and sites. Her background includes a Bachelor’s degree in molecular biology, a Master of Public Health in epidemiology, and professional certification through the Association of Clinical Research Professionals (ACRP).

Jwalant (JD) is a highly accomplished professional with over two decades of expertise in the biopharmaceutical industry, encompassing critical operations functions such as quality, manufacturing, supply chain, digital technology, and AI/ML operations. He has a strong record in leadership, management, strategy development, and execution, with extensive knowledge across biopharmaceutical operations, digital technology, financial analysis, and lean transformation. Currently, he leads digital QMS operations while spearheading the roll-out of AI-powered digital QMS operations, showcasing an innovative approach to digitization strategy. Passionate about driving digital transformation, Jwalant focuses on leveraging purposeful digitization and AI-driven innovations to optimize the end-to-end supply chain, improve patient care, and foster innovation in the biopharmaceutical industry. This highlights his commitment to revolutionizing the sector through innovative, data-driven approaches.

Rich has been in the life sciences industry for over 15 years. His career began in submission publishing, and he has gravitated towards the technology and process side of things over the past decade. Currently, he heads the regulatory, quality, and clinical solutions (RQCS) team at Mersana, where he creates and manages systems and processes for multiple areas.

Jennifer is a life science and pharmaceutical professional specializing in learning and development, documentation, ITQA, and continuous improvement. She focuses on establishing efficient processes to help clients work more effectively while understanding learning modalities and technologies. Jennifer is committed to analyzing, designing, and improving organizational processes by incorporating quality management principles while exceeding customer expectations.

Nick is the business owner for Vault Clinical Operations at Moderna and the global head of TMF operations, managing in-house and vendor teams. He has 25 years of experience applying computerized systems to speed drug development and improve quality, including IRT, TMF, RBQM, and eCOA. He is a member of the CDISC TMF Reference Model Steering Committee, working on projects related to digital data flow and the digital TMF.

As an executive director of digital quality at Moderna, Shiraz oversees digital strategic initiatives to align digital quality operations with corporate goals, ensuring a world-class quality ecosystem. Previously, she led strategic IT initiatives, including the Digital R&D Future Laboratory Platform. Notable achievements include establishing cross-company digital platforms and implementing continuous improvement processes. Shiraz excels in aligning IT strategies with business goals to drive innovation and operational excellence.

Luis is a quality control specialist with broad experience in the biopharmaceutical industry. Combining technical knowledge in biochemistry, microbiology, and cell and gene therapy, he excels at quality control laboratory processes. He is also proficient in quality systems, managing laboratory investigations, quality records, method transfer, and method validation. He promotes operational excellence and continuous improvement by using systems that promote quality, efficiency, and compliance for the quality control organization.

Janani is a managing consultant at NNIT with over 8 years of advisory, business and operations expertise within pharma and regulatory landscape. For the last six years in consulting, she has led several large-scale implementation and transformation projects to address challenges across data, systems and user experience.

Christina (MD, MBA) has devoted her career to clinical research and currently serves as Northwell Health’s senior vice president of clinical research. Committed to the advancement of science and medicine, Dr. Brennan has more than 24 years of extensive clinical research experience, including over 19 years in clinical research management roles. She received the Christine Pierre Clinical Trials Lifetime Achievement Award in 2023. Dr. Brennan has authored textbook content, coauthored many manuscripts and abstracts, and has presented at numerous scientific and research meetings. She is also adjunct faculty for Yeshiva University for their Master of Science program for clinical trial management and entrepreneurship.

Jose is a pharmaceutical/biotech director with a track record of leading, planning, and executing strategies for global drug development, regulatory submissions, business systems technology processes, and life cycle management. He has a proven record of successful regulatory submissions and approvals in multiple regions (e.g., FDA, EMA, LATAM). Jose is highly effective in managing cross-functional team performance, removing obstacles, and creating a framework that sets clear and high expectations to empower them to create impactful work.

Joe is a seasoned professional with a substantial background in clinical systems and data management. He has been instrumental in implementing sophisticated clinical technologies across remote platforms. Joe’s expertise spans data visualization, reporting and analysis, electronic data capture (EDC), and clinical data programming.

Christie is a seasoned clinical research professional with an impressive 35-year career spanning roles across the industry, and has been with Parexel for 26 years. Christie has excelled as a system owner and solution enablement lead, successfully implementing numerous systems and representing business solutions. Christie’s foundation in clinical research was built as a research site director and clinical research associate.

Naresh serves as the vice president of data and technology at Parexel, bringing over two decades of expertise in developing and implementing cutting-edge enterprise and clinical solutions for the clinical research industry. With 22 years of experience, Naresh leads the Vault Clinical platform and oversees a comprehensive range of clinical technologies. His responsibilities include fostering innovation, executing key initiatives, and ensuring superior service delivery to optimize operational efficiencies and customer success. Naresh recently led a successful implementation of Vault CTMS. He holds a master’s degree in computer applications, his strategic approach continues to play a crucial role in technological innovation, contributing to more efficient and effective clinical trials.

As Parexel’s chief strategy officer, Kushal is an enterprise-wide strategic partner and thought leader who implements large-scale organizational plans. Since joining Parexel in 2013, he has held roles of increasing responsibility and accountability in sales operations, corporate development, and strategy. His earlier career included positions in brand management, market research, and account management. Kushal holds a Master of Business Administration from the MIT Sloan School of Management, and a Bachelor of Pharmacy from the University of Pune (India). He is a registered pharmacist under the Pharmacy Council of India, and earned master’s degrees in drug development and marketing from the University of Cincinnati.

Saubiya oversees quality event management, vendor quality, and controlled document management processes. She will also spearhead initiatives to continue growing and enhancing quality governance, analytics, and risk management for strategic partners. Saubiya brings over 20 years of industry experience from her tenure at GSK, where she led teams in global ethics and compliance, third-party oversight, and quality and risk management. Saubiya has a Bachelor’s degree from Boston’s Northeastern University and a Master of Science from the London School of Economics, UK. She is certified as a Six Sigma Black Belt and Project Management Professional (PMP).

Katie is the associate director of clinical study business operations at Praxis Precision Medicines. She is responsible for the oversight of all TMF operations. In the last six years, she has built the TMF operations function from the ground up. She implemented Veeva Vault eTMF, developed best practices and SOPs, and cultivated an energetic environment centered around stakeholder investment in TMF.

As PwC’s global lead for quality, Sam has helped several life science companies digitize the quality processes that drive not just improved compliance but also, help drive greater operational efficiencies. This includes exploring how the use of AI can reduce the overall cost of quality by helping to automate “administrative” and/or highly administrative tasks often embedded into his client’s quality management systems.

Shauna excels in creating and executing comprehensive training programs that meet organizational objectives and regulatory standards. With a strong emphasis on fostering employee growth and a background in compliance and quality systems, Shauna has effectively led training teams to ensure compliance with regulations and enhance operational efficiency. Shauna holds a Master of Science in corporate and organizational communication from Northeastern University. She has a proven track record of driving success in biotechnology through her strategic leadership and innovative training methods. Shauna’s Coffee & Compliance approach uniquely engages learners, providing content that can be consumed while enjoying a cup of coffee.

Dawn is a dedicated researcher with 20 years of experience in the pharmaceutical industry. For the past six years, she has supported the Veeva Vault Quality Management system as a business administrator, providing technical and process expertise. Dawn specializes in reporting and analytics, enhancing quality management processes through insightful reports and detailed analyses. Passionate about maintaining excellence, Dawn is committed to continuous improvement in all aspects of quality.

Tamara is an expert in strategic implementations, legacy process assessments, and large-scale transformations, with a strong focus on digital systems in the biotech industry. As the director of quality applications at Resilience since May 2021, she oversees QA and QC applications. Tamara has successfully implemented Veeva globally, transitioning seven sites to new DMS, LMS, and QMS platforms. She also led the implementation of the RIM, supplier quality, and Vault modules. With nearly a decade of experience and a Master’s in regulatory affairs, Tamara excels in IT and quality system program delivery, business strategy, and regulatory compliance.

Faizan is passionate about technology, science, and data and their use in healthcare to enhance employee engagement and transform patient outcomes.

Jasmine is a regulatory informatics product manager at Roche with over 15 years of pharma regulatory experience within business and informatics. For five years, she has led several organizational transformation projects, most recently as a product manager/release lead for the E2E regulatory information management (E2E RIM) program. She also has 11 years of experience in people management.

Christine is the head of global submissions management at Sanofi, bringing extensive expertise in clinical development and regulatory affairs. Renowned for her ability to drive transformational change, Christine is always looking for innovative ways to enhance process efficiency while maintaining the highest quality standards. Her visionary leadership and relentless pursuit of excellence make her a pivotal force in the industry.

Tejas has over 23 years of experience managing complex transformation projects, programs, and application portfolios in the regulated pharmaceutical industry. Currently, he is Sanofi’s digital service line manager for digital global regulatory affairs (GRA). In this role, he leads the development, enhancement, and maintenance of the GRA technology strategy and solutions, ensuring alignment with the overall GRA/Digital GRA strategy and roadmap. Tejas ensures that all internal and external solutions operate efficiently, meet quality standards, and stay integrated with Sanofi’s strategy and internal standards. Tejas works closely with business and digital stakeholders and the senior leadership team to deliver technical capabilities that provide significant business value.

Ijeoma has over 18 years of experience in healthcare operations and quality management. Her industry experience includes GVP, GCP, GLP, and GMP. She currently leads pharmacovigilance operations, quality management, and safety systems at Sarepta Therapeutics. Ijeoma is passionate about patient safety, process design, and operational excellence. She has a B.Sc. in biochemistry and a master’s in health administration.

Wim has been the regulatory information and document management system (RIMS/DMS) lead at Sarepta Therapeutics since June 2021. He is responsible for access to and training on Vault Registrations, Submissions, and Submissions Archive. He collaborates cross-functionally to implement complex changes and to keep RIMS/DMS in a validated state. He was crucial in successfully implementing the connector between Vault QMS and Vault RIM. He works cross-functionally to initiate the connector implementation between the PromoMats, Clinical Vaults, and Vault RIM. Most recently, he kicked off the cross-vault governance center of excellence at Sarepta.

Dave is the vice president of strategy at Scitara Corporation. With experience in strategic domestic and international software development, project management, and sales within the life science marketplace, Dave is responsible for leading the global product innovation strategy. Over his 30-year career, Dave has held roles at leading life science software companies, including NuGenesis Technologies and CambridgeSoft Inc., and most recently at PerkinElmer, where he was responsible for leading key strategic accounts.

Alisha has been dedicated to the progression of evidence-based research for more than 12 years. Her experience working within site, CRO, and sponsor settings has provided her with a unique and well-rounded research background. Alisha began the framework of what would become Skylight Health Research as a small department in a large primary care company, building the program from the ground up before separating into a stand-alone company in 2023. She aims to empower patients, staff, and providers to understand the breadth of difference they can make in the world.

Michelle has over 25 years of experience in leadership and strategy roles across various operational areas. She helped start, grow, and later re-invent IRT at a major CRO and shepherded technology development for a specialized late-stage team there. She has pushed innovation within multiple EDC build teams, directed data sciences in an oncology biotech, and transformed a leading CRO’s multi-division sales team to a single process powered by a major cloud-based CRM. Currently, she heads full-service clinical systems delivery and is the business owner for Veeva CDMS and CDB as part of the larger team implementing Veeva across Syneos Health.

Mike, head of customer success at Syneos Health’s FSP 360 division, leading the strategic optimization of customer engagements. With over 24 years of industry experience in clinical and biometrics delivery, he leverages people, processes, and technology to deliver exceptional value. Mike is dedicated to meeting current market needs and driving future delivery evolution to ensure customer success.

Peter serves as the process excellence and delivery director at Takeda Pharmaceuticals. In this role, he is dedicated to helping to further the strategic advancement of Clinical Site Startup & Engagement (CSSE) through innovation and excellence. Peter leads and supports the implementation of process optimization by aligning with business practices. He has extensive experience in several therapeutic areas including oncology, infectious diseases, gastroenterology, dermatology, cardiovascular, neuroscience, rheumatoid arthritis, and rare diseases. Peter holds a PharmD degree from Semmelweis University in Hungary and a secondary master`s degree with an emphasis in Health Economy from University of West Hungary.

Priya is an experienced leader, steering the strategic direction and implementation of cutting-edge strategies for clinical studies. She has demonstrated proficiency in guiding teams through the process of setting up configurable data pipelines. Priya’s end-to-end knowledge of clinical research helps facilitate the seamless execution of in-house studies, optimizing data collection and data management solutions for clinical trials. She has a track record in wide variety of roles in clinical research and healthcare.

Jose is a seasoned product manager at Translations.com, the technology division of TransPerfect, specializing in translation and localization technology. With a wealth of experience in the field, Jose has spearheaded numerous projects, including the seamless integration of Veeva Vault products with GlobalLink, a cutting-edge translation management system. His expertise spans complex implementations within the life sciences industry, focusing on AI and automation.

Ty leads the AI consulting and implementation practice group in TransPerfect’s artificial intelligence division. He specializes in developing program-level initiatives to maximize Veeva’s efficiencies and savings.

Amy is a successful IT executive with experience across multiple industries, including high tech and pharmaceuticals, for over 30 years. She oversees the cybersecurity program, SOX IT general controls, and the deployment of enterprise business applications, software-as-a-service (including over a dozen Veeva Vault and Veeva CRM implementations), and business intelligence solutions. She is passionate about supporting and mentoring women in STEM as a committee member for the San Diego Women in Technology group within the Society of Information Management.

Hovsep is the Vice President of Strategy and Operations, driving cross-division alignment and operational enablement across USDM. Hovsep also leads USDM’s Veeva services practice. He has 20 years of experience managing projects and programs in the life sciences industry, specifically focusing on implementing and optimizing enterprise SaaS systems, strategic consulting for executive leadership, and business and digital transformation guidance in life sciences.

Nagesh is a senior executive and Fortune 500 change agent who boasts over two decades of success in building, steering, and growing start-ups into global leaders. He leverages 30 years of progressive global business development, software development, project management, service delivery, and systems integration experience to transform life sciences challenges into a source of advantage via regulatory, quality, clinical, safety, and production IT. Nagesh serves as a senior leader of NNIT Inc. and its Global Migration Powerhouse.

Tina is an accomplished and performance-driven healthcare leader with 25+ years of leadership roles clinical research positions with a patient-centric focus. She has expertise conducting phase I-IV clinical trials (including laboratory processing), clinical operations, budgeting, quality control, and compliance for human subject research with a focus on oncology. Tina has a well-rounded background and deep understanding of the different pillars among clinical trial teams, including clinical operations, regulatory, and finance.

Chris is the associate director of quality control at Verve Therapeutics. Verve is implementing LIMS in the internal start-up laboratory. Chris has implemented new QC labs at previous companies and implemented and upgraded LIMS at these labs. His interests are all areas of quality and maximizing efficiencies from sample receipt to batch disposition.

Hardy is a regulatory operations professional at Vir Biotechnology, Inc. with over 12 years of experience in publishing eCTD submissions to the FDA, electronic platform management, and now business administrator of Veeva RIM, including the Submissions Publishing module. His career began in regulatory publishing (paper submissions) and, over the past decade, has gravitated towards the technology and process side of the business. Prior to Vir, he worked at several other biopharmaceutical companies, including ImmunityBio, NantKwest, Endo Pharmaceuticals, and Anchen Pharmaceuticals.

Eric is a developer support engineer, responsible for ensuring that customers have an amazing experience with Vault developer tools and representing the voice of the developer for the Veeva Vault product team. He provides support to partners, consultants, and customer developers, and serves as an API/SDK advocate for the company, presenting to developer audiences on new features and best practices.

20+ years in Regulatory, 13 years in industry & 7+ years at Veeva.

Nick is a clinical data solutions consultant at Veeva, where he is tasked with gathering technical requirements and challenges from customers and presenting a solution that addresses those complexities while showing the value of the Veeva Clinical Data platform. Before joining Veeva in 2022, Nick worked with various technologies at organizations such as SCA Pharma, Premier Research, and most recently as a solutions consultant at Clarion (formerly Bioclinica), where he provided product expertise for their full software solutions suite. His passion for product and platform excellence led him to Veeva, where he applies his years of software experience to show the value using modern and truly unified clinical data tools can provide to sponsors, CROs, and patients.

Sam is part of the Veeva Clinical Data Strategy team where he supports clinical development transformations, with a focus on scaling new technology. Prior to Veeva, Sam spent time working in technology and pharma implementing real world data registry studies, EHR connections, remote patient monitoring solutions, and eCOA.

Andy is the vice president of product management for Vault Platform. Andy’s team is focused on delivering a robust platform for the rapid development of Vault Applications. He has more than 20 years of enterprise software experience and has held product positions at NextLabs, Siebel Systems, and Accenture.

Brian has been with Veeva since 2017 and currently leads the product team in Vault Clinical, responsible for Vault eTMF, Study Startup (SSU), and certain functionality that crosses the product suite. Before Veeva, Brian spent three and a half years at Bioclinica, where he led product design and delivery for enterprise data warehouse, reporting, and analytics using EDC, RTSM, and CTMS data. He also led their RBM product. Before that, Brian led Informa’s Medtrack product, which was a searchable database covering corporate, scientific, and financial data across the life science industry.

Bryan is focused on building the best digital identity experience for external users. Bryan brings over 10 years of SaaS experience to Veeva. He’s worked as a product manager and data scientist for various Silicon Valley companies: Atlassian, Invoice2go, and Lookout.

C.J. is a senior consultant on the Vault Safety professional services team. During her five year tenure at Veeva, she has worked on a range of different Vault applications, including Vault RIM (Regulatory) and Vault Safety. C.J. is currently focused on developing the Vault SafetyDocs application in partnership with Veeva strategy and product to deliver a robust solution for risk management and literature monitoring, as well as enhancing the Vault Safety-RIM connection.

Drew’s career in pharmaceutical technology spans over 20 years. It includes significant experience in eClinical system architecture, design, and development, as well as process design, solution validation, and international implementation and support. Drew joined Veeva in 2016 as vice president of product management and led the ground-up design of Veeva’s Vault EDC solution. As chief technology officer for Vault CDMS, Drew shares and collaborates with customers, partners, and the industry to set the vision and direction of Veeva’s CDMS product.

As vice president of product management for Vault Safety, Eldar is responsible for the product teams for Safety, SafetyDocs, Workbench and Signal. Eldar has over 20 years of experience in enterprise software, delivering innovative and industry-leading technology solutions across the globe.

Elizabeth is a life science industry professional with a background in education from West Chester University. Her career spans various roles focused on both GxP and non-GxP training and development. Initially at a startup biotech company, Elizabeth was a subject matter expert on a team that implemented a GxP based Learning Management System (LMS). She then spent three years at UL ComplianceWire, where she specialized in administering and managing LMSs and training programs for various Life Science organizations. Currently, as a senior manager at Veeva, Elizabeth plays a crucial role in expanding Vault Training within the marketplace. She offers valuable insights to prospective Veeva customers and existing clients on building and sustaining effective training initiatives helping organizations achieve ongoing success, while also providing product guidance to meet the ever-changing needs of the industry.

Eric is the senior product manager for Vault SafetyDocs. Eric was previously a product manager on the Vault Safety team, working on features across Vault Safety Management. The main areas he worked on in core Safety are follow-up, SDK, narratives, medical review timeline, distributions, and correspondence.

Graham is responsible for Vault Platform Services which includes Common Components, Mobile, Reports, and Workflows. Prior to joining Veeva in 2015, Graham was an associate at an early stage VC firm and a consultant at L.E.K. Consulting. Graham holds bachelor’s degrees in economics and business from UC Berkeley, and a master’s degree in computer science from UIUC.

Graham has spent his entire career working in the life sciences in the quality space for companies including Pfizer, J&J, Merck, Baxter, Boston Scientific, and now at Veeva Systems. As general manager for LearnGxP, he is helping companies deliver engaging online compliance and regulatory training to ensure workforces remain focussed on product quality and customer safety.

Jason is an industry veteran with over two decades of multifaceted roles within pharmaceutical quality control. Through leading multiple global LIMS programs, building lab informatics support services, and owning lab platforms, Jason brings a honed perspective to leading the market strategy for Veeva Vault LIMS.

Justin is a member of Vault Quality strategy, focused on the unification of quality assurance and quality control within Vault LIMS. As a laboratory informatics professional, he brings over 16 years of experience partnering with manufacturing and quality organizations to optimize efficiency, accessibility, quality, and compliance through digital transformation.

Kaitlyn is the senior product manager in the Clinical Operations Suite, working on Vault Disclosures, with over ten years in product management for clinical trials, health care, and population health. Kaitlyn brings a passion and focus on user experience to the product design process and proven experience in new product launches from inception to delivery. Kaitlyn earned an undergraduate degree from UNC-Chapel Hill and an MBA from NC State University.

Kelly is a RIM Registrations product manager responsible for structured data reporting standards including XEVMPD and IDMP. She has been with Veeva for 5 years.

Serving as vice president of strategy for Veeva Site Connect, Kenny has built connected ecosystems with integrated clinical technologies that streamline sponsor-site engagement for the world’s largest biopharmaceutical companies. In his tenure, his thought leadership supported the development of Federal Health IT Standards as well as the Code of Federal Regulations on Electronic Prescribing of Controlled Substances (21 CFR Part 1311) to combat the national Opioid epidemic. Kenny co-founded a federal program that brought Health IT to medically underserved areas across the United States and is an experienced leader in the clinical implementation of technology.

With over four years at Veeva and more than 14 years in the pharmacovigilance and safety domain, Mami specializes in global pharmacovigilance systems and safety process optimization. She has extensive experience with PMDA (Japan), FDA(US), and EMA, and is expanding her expertise to include MFDS (Korea) and NMPA (China)

Manaphan joined Veeva in October 2016 and has held product leadership roles in commercial content and Asia. He is currently the senior director of product management for Vault QMS. Manaphan is passionate about making products that customers love to use and building software solutions that simplify the complex. Before joining Veeva, he spent more than 15 years supporting, implementing, and building sales and marketing automation software across multiple verticals and geographies. Manaphan received an MS in computer science from Boston University and a BBA in MIS from the University of Texas at Austin.

Manny has spent almost 20 years in Clinical Data Management, starting in a small oncology biotech before moving to the CRO space for ten years. In early 2022, Manny joined Veeva Systems to support strategy for the Clinical Data suite of applications.

Marius is the principal product architect for Vault Safety. He has built world-class products and platforms across various industries for 20 years. Marius joined Veeva in 2015, working on the Vault Platform and has been focused on helping life sciences organizations innovate and solve complex problems ever since. In 2017 his attention turned to Pharmacovigilance. Before Veeva, Marius worked at D+H (now Finastra), a top 20 FinTech, building their enterprise lending compliance platform and designing their next-generation products.

Mark is responsible for helping to enrich the developer experience for Veeva Vault. He takes feedback from customers and internal resources and uses industry best practices. Mark manages the world-class integration features for the Vault Platform.

As the director of clinical strategy for Vault Disclosures, Matt’s 15-plus years of expertise lies in driving growth within the disclosures customer base and charting the path for the advancement of the Vault Disclosure product capabilities. His involvement extends to various critical facets of market-facing operations, supports customer demos, collaborates seamlessly with the services team to propose optimal solutions, and works closely with sales to ensure successful deal closures. Moreover, Matt plays a key role in product strategy, working closely with product management to plan and prioritize future product functionality. Beyond that, he spearheads the development of strategies and relationships with key partners, ensuring that Vault Disclosures stays aligned with market demands and remains at the forefront of innovation.

As a product expert for Vault Platform, Mike focuses on providing education on Platform functionality through Veeva Connect Communities and helping ensure that customers have the best possible information to adopt and leverage Vault Platform functionality. Within the Vault Platform team, he works closely with the PMs and product experts. At a high level, Mike’s focus areas within Vault Platform are Docs (including Document Viewer, Renditions, and Core Doc functionality), Vault Mobile, Expected Document Lists, Reports and Dashboards, and Security.

For the past 18 years of Mike’s career, he has been focused on and worked with many of the top pharmaceutical and biotechnology companies to lead PV process and system optimization efforts. During this time, Mike has helped his customers with defining their business vision and strategy, operational roadmaps, system analysis and optimization, system implementation and integrations, business process analysis and operational improvement projects. Mike joined Veeva Systems in February of 2020 to partner with the Vault Safety Strategy team to focus on growing the product’s capabilities and delivering on customer success goals.

Pavel developed clinical data expertise as a statistical programmer. He found success in clinical data collection and analysis, where processes and technology meet. His proudest moments came when building global programming and training teams to deliver results for customers. In 2020, Pavel established the CDB Services team at Veeva. Over 18 months, this team enabled CDB, early adopters, to establish expertise and scale. As general manager, Pavel is now driving CDB toward transforming data management.

Peter is the director of product management for the Vault Validation Management application at Veeva Systems helping the life sciences industry transform their validation processes. Peter has worked in industries ranging from the power generation and the utility sectors to manufacturing of industrial inkjet systems and cloud QHSE software. Most of his career was spent in manufacturing in engineering, quality, and new product development, and has spent the last eight years focused on product management, developing cloud QMS solutions. Peter has a degree in mechatronics engineering from the University of Toronto and an MBA from the Rotman School of Management.

Raymond leads the development of Veeva Vault CDMS, helping customers improve data quality and speed while reducing the cost and complexity of clinical trials. With over 25 years of experience in delivering enterprise and cloud-based software, Raymond brings a wealth of expertise to Veeva. He joins Veeva from Medrio, Inc., where he served as chief operating officer and head of product, overseeing the product roadmap and delivery of their cloud-based eClinical EDC and eSource products. Through his extensive experience, Raymond has gained firsthand knowledge of the best practices and challenges faced by product, engineering, marketing, and sales teams in bringing technology products to market.

Rich is a strategic thought leader in life sciences technology, specializing in regulatory information management. His extensive experience has been instrumental in developing innovative software solutions that empower organizations to accelerate time-to-market while ensuring compliance. At Veeva, he leads the product management team responsible for Vault RIM, driving the future of regulatory solutions.

Stephen joined Veeva in January 2022 and has been leading the Vault QualityDocs and Vault Station Manager products within the Quality Suite. Before joining Veeva, Stephen spent almost 15 years in the healthcare technology industry in a variety of technical roles helping transform healthcare via digitization. Most recently, he helped lead the product strategy and execution of a couple of B2B2C consumer health products. Stephen has a bachelor’s degree in computer engineering and a master’s degree in computational biosciences.

Steve has over 22 years of life sciences experience spanning everything from Clinical to Commercial. A Veeva veteran of over 11 years, Steve knows what it takes to make customers successful with Veeva products. As General Manager for Veeva RTSM, Steve focuses on bringing the Veeva values to the Randomization and Trail Supply Management space by delivering a better product and better services to this critical area.

Tim has over 25 years of experience working in the life sciences industry from a pharmaceutical company, CRO, and technology vendor perspective. Most notably, he was the founder and CEO of Exco InTouch Ltd, a patient engagement and eCOA mobile application provider, which he scaled through to a successful trade sale and exit in 2016. Tim is currently vice president of Strategy at Veeva Systems. His primary focus is on the strategic development of MyVeeva for Patients, a patient-facing application suite.

As director of product management for Vault Safety, Tristram leads a team responsible for Aggregate Reporting, Workbench and Signal. He has over fifteen years of experience in product management building regulatory reporting and data analysis solutions.

Vinny is the vice president of site connect strategy on the clinical operations team. He has spent much of his career in the life sciences space and has always been interested in pursuing innovative ways to improve the industry. At Veeva, Vinny continues to work on features that span Vault Clinical Operations and SiteVault, including those designed to enhance the collaborative experience between sponsors and site.