Lead the end-to-end TMF strategy, including the transition from outsourced to in-house operations, ensuring control, scalability, and quality across all clinical studies. Define and implement TMF governance, processes, and standards to ensure consistent document organization, classification, and filing in alignment with regulatory requirements and industry best practices. Serve as the TMF subject matter expert, establishing clear expectations for document structure, naming conventions, indexing, and lifecycle management. In partnership with Clinical Operations study lead, oversee TMF health across all studies, ensuring completeness, accuracy, and inspection readiness at all times through ongoing quality control and reconciliation. Lead TMF activities across the study lifecycle, including study start-up, maintenance, and close-out, ensuring proper documentation, completeness reviews, and archival readiness. Own and execute TMF migration efforts ensuring data integrity, completeness, and alignment with Kyverna standards. Assess and evaluate TMF system providers by defining requirements, conducting vendor assessments, and leading cross-functional reviews to identify a compliant, scalable, and inspection-ready solution. Partner closely with Clinical Operations, Clinical Development, Regulatory, Quality, IT and external partners to ensure seamless document flow and accountability. Operate comfortably in both strategy and execution, including direct involvement in document review, filing quality, and issue resolution. Establish TMF metrics and KPIs to proactively identify risks, drive continuous improvement, and ensure sustained inspection readiness. Support regulatory inspections and audits as the TMF lead, ensuring readiness and effective responses to health authority inquiries.
