• Provide leadership and oversight of TMF operations, ensuring inspection readiness and compliance with global regulations and internal standards. • Manage and mentor TMF staff, fostering a culture of accountability, quality, and professional development. • Oversee and optimize use of Veeva Vault eTMF and ensure alignment with business needs and best practices. • Partner with Veeva Managed Services and Clinical Systems Manager to resolve issues, implement system enhancements, and ensure operational excellence. • Lead TMF metrics and reporting, including completeness, timeliness, and quality, providing transparency to senior leadership. • Serve as a subject matter expert for ICH GCP, GDocP, CDISC TMF Reference Model (formerly DIA TMF Reference Model), and global clinical trial regulations. • Support with audits and regulatory inspections, including preparation, backroom support, and follow-up activities. • Support CAPA management: drafting, implementation, tracking, and closure for TMF related quality events. • Support authoring, reviewing, and maintaining SOPs, Work Instructions, and training materials, plans related to the TMF. • Support in maintaining and performing change control on company TMF Content Map. • Drive change management initiatives to improve TMF processes, systems, and culture in a matrixed environment. • Partner with stakeholders on process improvement projects and conduct TMF training across clinical and study teams. • Ensure proper TMF configuration and adoption that may have impact on adjacent Veeva Clinical Suite applications such as, CTMS, Site Connect, Study Training, Study Start-up. • Collaborate cross-functionally to ensure TMF expectations are clearly defined, implemented, and monitored throughout study lifecycles. • Other duties as assigned.