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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Treat FSP Staff As Integrated Team Members
- When using FSPs, align expectations, governance, and processes so CRO staff operate indistinguishably from sponsor staff.
- Equip them with sponsor tools (email, laptops, iPads) and regular partnership forums to keep the team seamless.
Peloton Integration Built A Playbook
- During the Peloton integration, Merck prioritized face-to-face contact and retention to preserve expertise and complete registrational work.
- Sheller had an intern build a playbook during the integration that became Merck's standard for future integrations.
Design Lean, Fit-For-Purpose Protocols
- Design lean protocols by starting with the research question and removing copy-pasted procedures that add site and patient burden.
- Tier exploratory and secondary measures, use sub-studies, and favor remote visits where appropriate to reduce workload.