Associate Director, TMF Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct the comprehensive TMF strategy, overseeing the shift from outsourced to in-house operations, while ensuring control, scalability, and quality across all clinical trials.

• Establish and enforce TMF governance, processes, and standards to guarantee consistent document organization, classification, and filing that aligns with regulatory demands and industry best practices.

• Act as the TMF subject matter expert, setting clear expectations for document structure, naming conventions, indexing, and lifecycle management.

• Collaborate with the Clinical Operations study lead to monitor TMF health across all studies, ensuring completeness, accuracy, and readiness for inspections at all times through ongoing quality control and reconciliation.

• Oversee TMF activities throughout the study lifecycle, including initiation, maintenance, and closure, ensuring proper documentation, completeness reviews, and archival readiness.

• Manage and implement TMF migration efforts, guaranteeing data integrity, completeness, and alignment with Kyverna standards.

• Evaluate TMF system providers by defining requirements, conducting vendor assessments, and leading cross-functional reviews to pinpoint a compliant, scalable, and inspection-ready solution.

• Collaborate closely with Clinical Operations, Clinical Development, Regulatory, Quality, IT, and external partners to ensure smooth document flow and accountability.

• Navigate both strategic and execution facets comfortably, including direct involvement in document review, filing quality, and issue resolution.

• Develop TMF metrics and KPIs to proactively identify risks, encourage continuous improvement, and maintain sustained inspection readiness.

• Act as the TMF lead during regulatory inspections and audits, ensuring readiness and effective responses to inquiries from health authorities.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field; advanced degree is preferred.

• Over 10 years of clinical research experience with a significant emphasis on TMF management.

• Demonstrated experience in overseeing TMF operations, encompassing both strategic direction and hands-on execution.

• Proven track record of transitioning TMF activities from outsourced to in-house models.

• Strong proficiency in Veeva Vault eTMF, including implementation, migration, and ongoing management.

• In-depth knowledge of TMF structure, document taxonomy, and regulatory requirements (FDA, EMA, ICH-GCP).

• Experience managing TMF throughout the complete study lifecycle, including closure and archival processes.

• Background in leading TMF migration initiatives focusing on quality and compliance.

• Experience in biotech or cell and gene therapy.

• Proven experience supporting regulatory inspections and audits.

• Experience in building or scaling TMF capabilities within a developing organization.

🏝️ Benefits

• Bonus

• Benefits

• Participation in Company’s stock plan