Associate Director, TMF Management
Virtual Vocations Inc, New York, NY, United States
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
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