Business Of Biotech Modernizing Clinical Trial Operations With Merck's Jennifer Sheller
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Dec 22, 2025 In this engaging discussion, Jennifer Sheller, SVP of Global Clinical Trial Operations at Merck, shares her extensive experience in clinical development. She delves into the challenges of global trial coordination and the shift from traditional to modern practices in healthcare. Jennifer advocates for simplified protocol designs and highlights Merck's innovative hybrid model for trial management. She also emphasizes the importance of integrating acquired teams while preserving talent and continuity in studies, all while leveraging technology to enhance efficiency.
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From Lab Student To Clinical Operations
- Jennifer Sheller stumbled into clinical trials after studying molecular biology and public health and starting as a clinical research assistant at Covance.
- Early hands-on site work shaped her operational, problem-solving approach to running trials.
Paper To EDC Was Big — Standards Remain
- Clinical R&D volume exploded since the late 1990s, with half a million trials on clinicaltrials.gov.
- The big operational shift was paper to electronic data capture, but standardization across countries remains a major modernization gap.
Hybrid Outsource Model Beats Pure Outsource
- Outsourcing swung from fully insourced to fully outsourced and now to hybrid models across industry.
- Merck's FSP approach (≈60% employees, 40% FSP) creates one-team processes and better integration with sites.