Associate Director - Tmf Management
Current• Accountable for implementation and maintaining control of record management and archival processes related to the electronic Trial Master File (eTMF) and to ensure compliance with internal policies as well as external regulations. • In collaboration with the Global TMF team, review eTMF best practices, develop strategic and tactical plan to improve global eTMF process management.• Serve as a Subject Matter Expert and ensure GxP inspection readiness for Clinical Study TMF documentation and records for inspection by internal or regulatory agencies. • Participate in drafting and updating eTMF SOPs and Work Instructions.• Ensure high quality TMF set-up and management, including Expected Document List and Milestones set up for the studies• Lead the internal periodic quality check (QC) activities of the TMF, provides findings to the clinical team and provides support to the team to ensure compliance is maintained • Establish Key Performance Index (KPI) and metrics to measure TMF Quality, Completeness, and Timeliness.• Serve as a point of contact to work with Veeva Managed Service to create reports and dashboards for eTMF users and clinical study team• Lead the activities for TMF migration from CRO to sponsor, including the preparation of Request for Proposal (RFP) and vendor selection process.• Partner with System Admin and QA to review the quarterly Vault eTMF system update and implementation of configurable updates• Develop training materials for Vault eTMF users and conduct training/workshops• Serve as a core member in the Veeva CTMS implementation, defining requirements for integration with the existing eTMF system
