Associate Director, TMF Management

Job Summary

A company is looking for an Associate Director, TMF Lead to oversee the strategy and execution of an in-house Trial Master File function.

Key Responsibilities

• Lead the end-to-end TMF strategy and transition from outsourced to in-house operations
• Define and implement TMF governance, processes, and standards to ensure compliance with regulatory requirements
• Serve as the TMF subject matter expert, overseeing document structure, lifecycle management, and inspection readiness

Required Qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred
• 10+ years of clinical research experience with a focus on TMF management
• Proven experience in leading TMF operations and transitioning activities from outsourced to in-house models
• Strong expertise in Veeva Vault eTMF and TMF structure
• Experience in biotech or cell and gene therapy and supporting regulatory inspections