Jenn Stamper

Just in Time GCP

With 20 years of experience in managing the Trial Master File (TMF), Jenn specializes in TMF oversight and inspection activities, providing clients with valuable guidance and expertise. She began her career with a Contract Research Organization (CRO) in the traditional paper format and has witnessed the evolution of electronic TMF (eTMF), including advancements in processes and regulations. Recognizing that clients are at different stages in their eTMF/TMF journey, Jenn is dedicated to helping them achieve a quality TMF that is compliant with Good Clinical Practice (GCP), complete, and ready for inspection. As a Director at Just in Time GCP, she leads the Services department, sharing her passion for the TMF through training and mentoring others in conducting record quality checks, quality and completeness reviews, high-risk assessments, and inspection readiness activities both within the TMF and on-site. Jenn is a core member of the CDISC Education Committee and actively participates in CDISC TMF Reference Model groups as a volunteer. She also presents at various industry events, sharing her insights and knowledge.