About
Jessica Ritchie Klein is a Senior Research Manager in the Department of Internal Medicine at Yale School of Medicine. She leads regulatory science initiatives including the Yale University Open Data Access (YODA) Project and the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI). Her work focuses on improving transparency in clinical trial data sharing and post-market medical device research. Klein holds a BS in Biological Sciences from University of Rhode Island and an MPH from Southern Connecticut State University, alongside a Project Management Professional (PMP) certification (2014).
Education:
- Bachelor of Science in Biological Sciences, University of Rhode Island (2005)
- Master of Public Health, Southern Connecticut State University (2011)
- Project Management Professional Certification (2014)
Research Interests: Klein specializes in regulatory science, clinical trial data governance, and healthcare outcomes research. Her work emphasizes ethical data sharing practices, improving transparency in medical research, and leveraging interdisciplinary collaboration to advance healthcare innovation. Recent projects include evaluating the concordance between clinical trial data proposals and resulting publications, and developing protocols for multimodal assessment of cancer patient physical function.
Key Contributions: Klein has co-authored over 10 peer-reviewed studies, with a focus on data sharing policies, medical device post-market surveillance, and collaborative research frameworks. Her work with the YODA Project has established best practices for accessing and utilizing clinical trial data. Klein also leads the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), fostering ethical standards in regulatory science.
Labs/Teams: She is affiliated with the Center for Outcomes Research and Evaluation (CORE) and serves as a core member of the Yale-Mayo Clinic CERSI and YODA Project teams.
