Associate Director, TMF Lead

Responsibilities:

• Lead the end-to-end TMF strategy, including the transition from outsourced to in-house operations.
• Define and implement TMF governance, processes, and standards to ensure consistent document organization.
• Serve as the TMF subject matter expert, establishing clear expectations for document structure.

Qualifications:

• 10+ years of clinical research experience with a strong focus on TMF management.
• Strong expertise in Veeva Vault eTMF, including implementation, migration, and ongoing management.
• Deep understanding of TMF structure, document taxonomy, and regulatory requirements (FDA, EMA, ICH-GCP).