Director of eTMF Management

Job Summary

A company is looking for a Director of eTMF Management & Inspection Readiness.

Key Responsibilities

• Lead the TMF framework, including strategy, governance, and standards for outsourced clinical trials
• Define and implement TMF processes and KPIs to ensure quality and compliance across studies
• Oversee eTMF system strategy, governance, and vendor performance while ensuring continuous inspection readiness

Required Qualifications

• 8-12+ years of clinical research experience with significant TMF/eTMF leadership experience
• Proven experience in building and leading TMF frameworks in outsourced or hybrid models
• Deep expertise in TMF strategy, governance, and health authority inspections
• Strong knowledge of ICH-GCP, TMF Reference Model, and global regulatory requirements
• Bachelor's degree in Life Sciences, Health Sciences, or related field; advanced degree preferred