× Patrick Nadolny has over 30 years of industry experience across pharmaceutical, device and biologics as well as technology development. He is a pragmatic leader focusing on technology, innovation, strategic planning, change management, and the setup of new capabilities. In addition to his SCDM Chair role, he leads the SCDM innovation committee, which recently released 3 reflection papers on the evolution of Clinical Data Management toward Clinical Data Science.

× Director, Program Lead in the Vaccines therapeutic area, Clinical Data Sciences department at Pfizer with over 30 years of experience in the biopharmaceutical industry, starting as a research protein biochemist and moving into the Clinical Data Management discipline in 2000. She has experience in both Early and Late Phase clinical development, both in project and people management. Her therapeutic areas of experience are in Cardiovascular/Metabolism, Inflammation, Immunology, Infectious Diseases, Rare Diseases, Ophthalmology and Vaccines. Carol has expertise in project and vendor oversight as well as global team leadership and governance. She holds both Bachelor’s and Master’s degrees in Biology (specializing in Biotechnology) from William Paterson University. She have been involved in SCDM for over 20 years, holding various volunteer positions (BoT, AC co-chair) and currently is the vice-chair of SCDM.

× Jonathan leads CRIO’s customer experience, engineering, product management, quality management and sales and marketing teams. With over 27 years of experience in operations, data management, quality and commercial operations, Jonathan brings a wealth of real-world experience. An active thought leader, blogger and presenter, Jonathan serves on the board and executive committee of the Society for Clinical Data Management (SCDM) and has been on the advisory boards of CDISC and DIA. Jonathan is co-lead with the Decentralized Trials and Research Alliance (DTRA) workstream initiative and a co-author on upcoming eCOA Consortium publications.

× Arshad Mohammed is the Global Head of Clinical Data Management FSP at Labcorp. He is a physician by training and brings over 20 years’ experience in the health sciences industry. Prior to the current role, Arshad has held a variety of roles in life sciences consulting, software product management, clinical data management, business development and electronic clinical outcomes assessments (eCOA). He has managed clinical data management teams across all phases of clinical development including early development, late phase as well as studies in the observational space. He is a Board of Trustee of the ‘Society for Clinical Data Management’. Arshad is an alumnus of Armed Forces Medical College, Pune and Indian Institute of Management, Ahmedabad.

× Dr. Grandinetti is the Associate Director for Clinical Policy within the Office of Scientific Investigations’ Division of Clinical Compliance Evaluation (DCCE) and provides leadership and subject matter expertise on policy issues related to good clinical practice, human subject protection, and clinical trial quality. She also serves as a subject matter expert in GCP inspections to evaluate data integrity, quality, and safety of human subjects in clinical trials.

× Beth Kunkoski currently works in the FDA’s Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP). She oversees several projects involving decentralized clinical trials, digital health technologies and electronic records and storage in clinical investigations (Part 11). She previously worked in the Center for Devices and Radiological Health (CDRH) overseeing the review of orthopedic devices. She earned a Master’s Degree in Biomedical Engineering and a Bachelor’s Degree in Chemical Engineering from the University of Michigan.