Manager, Medical Studies

About the role

The Manager, Medical Studies will lead the operational execution of externally sponsored research programs in Oncology and Neurology within Servier's US Medical and Patient Affairs department. Reporting to the Associate Director of Medical Study Operations, this role serves as the primary contact for external sponsors, investigators, and internal cross‑functional teams.

Key responsibilities

• Lead delivery of a portfolio of Investigator Sponsored Studies (ISS) and Collaborative Research Studies (CRS), ensuring milestones and governance requirements are met.
• Act as the main operational liaison for external sponsors and internal stakeholders, driving contract negotiations and budget development.
• Manage study financials, including Fair Market Value analysis, budget negotiation, and milestone tracking.
• Oversee clinical document review, supply logistics, and maintain inspection‑ready electronic Trial Master Files (eTMF).
• Identify and escalate program risks related to budget, timelines, and resources, and provide regular portfolio status updates.

Required profile

• Bachelor’s degree in a scientific or healthcare discipline.
• 3‑5+ years of experience coordinating clinical research studies, preferably in oncology, hematology, or rare diseases.
• Demonstrated ability to work with cross‑functional teams and manage external stakeholder relationships.
• Willingness to travel 20‑25% and work in a hybrid environment.

Required skills

• Expertise in research contracting, study budget management, and FMV analysis.
• Proficiency with research lifecycle platforms such as iEnvision, CyberGrants, IdeaPoint, and SteepRock.
• Knowledge of US and global regulatory requirements (ICH/GCP, GxP, CFR).

What we offer

• Salary range $145,000 – $166,000 with short‑term and long‑term incentive programs.
• Comprehensive benefits including medical, dental, vision, unlimited sick/flex time, 401(k), life and disability insurance.
• Opportunity to work in a purpose‑driven, fast‑growing biopharmaceutical company.