• Provide end-to-end oversight of the Trial Master File (internally and externally managed eTMF). • Serve as the eTMF business owner. • Ensure TMF completeness, accuracy, and timeliness in accordance with ICH-GCP, regulatory requirements, and internal SOPs. • Lead TMF quality review activities, including periodic QC, reconciliation, and ongoing completeness checks. • Ensure TMF inspection readiness and support internal, sponsor, and regulatory inspections and audits. • Manage and optimize TMF-related processes, standards, and SOPs. • Author and review clinical trial documentation, including TMF Management Plans, content list, study related plans, process documentation, training materials, etc. • Serve as a subject matter expert (SME) for the eTMF system, including configuration, taxonomy, metadata, and user adoption. • Develops requirements for reporting from the system, participate in UAT test script generation, UAT testing, and quarterly system update release review and approval. • Manage continuous improvement initiatives to enhance TMF quality, efficiency, and compliance. • Support TMF migrations, system upgrades, and vendor transitions as needed. • Partner with Clinical Operations, Clinical Trial Managers, Quality Assurance, cross functional members of the Clinical Sub-Team (CST) and external vendors to ensure TMF alignment and compliance. • Provide TMF guidance and training to internal teams and study partners. • Act as the primary TMF point of contact for assigned studies. • Manage CRO partners on eTMF-related activities. • Lead or mentor TMF managers, specialists, or vendors as applicable. • Contribute to TMF strategy, governance models, and global standards. • Support TMF-related risk assessments and mitigation plans.