Associate Director, TMF Management

Job Summary

Leading the strategy and execution of an in-house Trial Master File function, the full-time Associate Director, TMF Management will ensure all study TMFs are inspection-ready and aligned with global regulatory expectations while transitioning operations from outsourced to in-house.

Key responsibilities

• Lead the end-to-end TMF strategy, ensuring control, scalability, and quality across all clinical studies
• Define and implement TMF governance, processes, and standards for document organization and regulatory compliance
• Serve as the TMF subject matter expert, overseeing TMF health and ensuring completeness and accuracy throughout the study lifecycle

Required qualifications

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