Director, Trial Master File

Role: Lead the implementation, management, and continuous improvement of the Trial Master File (TMF/eTMF) systems and processes across clinical programs, ensuring inspection readiness and regulatory compliance. Responsibilities: oversee TMF system setup, develop standard workflows and SOPs, act as the subject matter expert, manage vendor performance, monitor TMF metrics, and ensure documentation quality throughout trial lifecycles. Collaborate closely with Clinical Operations, Quality, Regulatory, and IT teams to integrate TMF activities into study planning and execution, support audits, and lead quality control efforts. Requirements: 10+ years of biotech/pharma experience with proven TMF management expertise, system implementation, and process improvement skills. Strong knowledge of clinical trial management, GxP, ICH-GCP, and regulatory standards. Demonstrated ability to manage multiple projects, influence stakeholders, and lead change initiatives. HighValue: clinical trial documentation, TMF/eTMF system deployment, inspection readiness, process standardization, cross-functional collaboration, vendor oversight, continuous improvement. WorkSetup: not specified.