Externally Sponsored Research (ESR) Senior Manager, Clinical Operations

Revolution Medicines • Redwood City, CA

3d • Onsite

About The Position

This is a unique opportunity for an experienced Clinical Operations professional with strong expertise in Medical Affairs–owned Externally Sponsored Research (ESR) and a solid understanding of clinical operations, Good Clinical Practice (GCP), and U.S. Food and Drug Administration (FDA) regulatory requirements. Oncology experience is preferred.
As the Senior Manager, Clinical Operations, Medical Affairs ESR Program, reporting to the Director, Clinical Operations – Medical Affairs, you will be responsible for Clinical Operations oversight of ESR studies following approval, from protocol development through study close-out. This role serves as the primary Clinical Operations owner for ESR execution, ensuring compliant study activation, ongoing oversight, and documentation of sponsor responsibilities in alignment with internal SOPs and regulatory expectations.
Specifically, you will be responsible for:

Requirements

• RN or Bachelor’s or Masters degree in biological sciences or health-related field required.
• 10+ years direct Clinical Operations experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
• Direct experience supporting Externally Sponsored Research (ESR), Investigator-Sponsored Trials (ISTs), or Medical Affairs–led research.
• Strong working knowledge of FDA regulations, ICH guidelines, and GCP governing the conduct of clinical research.
• Experience with clinical trial budgets, FMV principles, contract amendments, and invoice review.
• Demonstrated ability to manage multiple studies and priorities in a matrixed, cross-functional environment.
• Excellent written and verbal communication skills.
• Demonstrated ability to anticipate operational risks, escalate issues appropriately, and execute with minimal oversight.

Nice To Haves

• Oncology clinical research experience.
• Global clinical research experience.
• Experience working closely with Medical Affairs and Field Medical teams.
• Familiarity with TMF systems, clinical trial tracking tools, and cross-functional governance models.
• Experience supporting regulatory submissions and safety reporting activities.

Responsibilities

• Clinical Operations functional activities related to the execution of Medical Affairs–owned ESR studies following approval, in alignment with department and corporate objectives.
• Acting as the Clinical Operations owner for ESR studies from protocol approval through final study close-out, including activation, conduct, and oversight activities.
• Coordinating the Clinical Operations start-up process for approved ESR studies.
• Oversight of contracting activities in collaboration with Clinical Site Contracts, including QC and routing budgets for Fair Market Value (FMV) review, supporting contract negotiations, applying study-specific milestones to contracts, and ensuring contract and budget amendments are executed.
• Serving as the primary Clinical Operations point of contact for ESR sponsors and sites once studies are approved.
• Supporting Regulatory Affairs by providing lists of ESR studies and participating countries, requesting and managing IND Right of Reference (RoR) letters, and tracking regulatory approvals.
• Ensuring readiness for site activation by confirming receipt and review of essential documents (e.g., IRB approvals, regulatory approvals, clinical trial registrations).
• Coordinating drug supply activities for all ESRs throughout the lifecycle of the ESR.
• Oversight of Trial Master File (TMF) documentation to ensure appropriate documentation of sponsor oversight throughout the study lifecycle.
• Tracking enrollment, milestone progress, and study status
• Ensuring enrollment logs and exposure data are provided to Regulatory and Safety to support DSURs, PBRERs, and other safety reporting.
• Review and approval of ESR invoices tied to milestone completion and reconciliation of payments.
• Partnering with Medical Science Liaisons (MSLs) on milestone tracking of enrollment and publication timing, as well as Clinical Operations trial insights.
• Managing study close-out activities, including drug accountability reconciliation, financial reconciliation, TMF completeness, and contract closure documentation.
• Participation in cross-functional team meetings and proactive identification, escalation, and resolution of operational issues.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level