Description

You will oversee Clinical Operations for Medical Affairs–owned Externally Sponsored Research (ESR) studies from protocol development through close-out, ensuring compliant activation, ongoing oversight, and documentation of sponsor responsibilities in alignment with SOPs and regulatory expectations.

Requirements

• RN or Bachelor's/Master's in biological sciences or health-related field
• 10+ years direct Clinical Operations experience in pharma/biotech
• Direct experience supporting ESR, ISTs, or Medical Affairs–led research
• Strong knowledge of FDA regulations, ICH guidelines, and GCP
• Experience with clinical trial budgets, FMV principles, and invoice review

Responsibilities

• Oversee Clinical Operations for ESR studies from protocol approval through close-out
• Coordinate start-up process, contracting, and Fair Market Value review
• Serve as primary Clinical Operations point of contact for sponsors and sites
• Track enrollment, milestone progress, and study status; support safety reporting
• Manage study close-out activities including drug accountability and TMF completeness