• Provide leadership and act as a Subject Matter Expert (SME) for TMF operations and requirements across study team functions, CROs, and vendors to ensure TMF content is timely, complete, and of the highest quality for in-house and outsourced studies • Build and maintain collaborative relationships with cross-functional partners, CROs, and external vendors to ensure expectations are clear, deliverables are met, and issues are resolved in a timely manner • Serve as an escalation point for study teams to drive resolution of issues, as appropriate • Ensure compliance with TMF Management SOPs, Good Documentation Practices (GDocP), ALCOA-CCEA principles (i.e. records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring & Available), applicable regulations, GCP requirements, and industry standards • Monitor and report KPIs to senior management, identifying trends across the portfolio, areas for improvement, and implementing changes as needed • Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required • Responsible for the management and leadership of a team of direct reports that will support the eTMF platforms and each study TMF including recruitment, training, mentoring, career development, work assignments, performance evaluations, and ongoing feedback • Assist with development and implementation of TMF processes, procedures, supporting tools, and TMF-related training materials that adhere to regulatory requirements and industry best practices • Review external TMF-related SOPs and associated documentation as needed • Author and review TMF Plans and associated documentation (e.g., TMF indexes/mapping, risk-based QC processes etc.), working with the cross functional study team to obtain necessary input • Oversee study teams in TMF closeout activities, including collection of study records from all vendors, end of trial TMF QC, and migration activities, if applicable • Oversee archiving activities to ensure adherence to processes and industry best practices • Ad hoc support of activities within the Clinical Operations team to help meet timelines and objectives including support with start-up activities, record collection and processing, QC, and/or archiving, as needed • Collaborate on projects with Information Technology (IT) to ensure effective implementation and integration of eTMF clinical systems • Lead and manage resolution of issues and remediation activities with stakeholders and the eTMF vendor • Serve as eTMF Business Owner and Administrator • Support integration of partnered or clinical information including TMF transfers in compliance with applicable regulations and best practice • Provide eTMF system training and acts as a primary support for users and study teams • Assist management with identifying areas of improvement and enhancements and obtains approval for system development projects