Senior Trial Master File Manager (Contract)

Job Title: Senior Trial Master File Manager (Contract) Job Number: 37421 Location: Remote Job Description The Senior Trial Master File (TMF) Manager oversees the daily management and maintenance of the TMF for assigned studies and reports to the Associate Director or Director. This individual serves as the primary TMF expert and key contact for the study team, working closely with cross‑functional partners to develop and manage study‑specific TMF documents such as the TMF Plan, TMF Index, and EDLs. The role focuses on maintaining quality and inspection readiness by tracking TMF health metrics, ensuring completeness, accuracy, and timeliness, and confirming compliance with standard operating procedures. It also includes supporting TMF reviews, resolving outstanding issues like CAPAs, and ensuring all documentation is up to date. In addition, the Senior TMF Manager contributes to broader initiatives led by TMF Management Leadership, including process improvements and strategic planning, while also managing TMF Specialists and overseeing external vendors. This is a 6‑month contract position, 40 hours/week. Responsibilities This role is accountable for managing the Trial Master File (TMF) throughout its full lifecycle—from initial setup to final archival—while ensuring quality, compliance, and inspection readiness in line with SOPs, GCP standards, and regulatory requirements. The position works closely with study teams and CRO partners to ensure the TMF is accurate, complete, and maintained on time. It also provides training and guidance to internal teams and external stakeholders on TMF systems, processes, regulations, and best practices, while building strong working relationships to support study deliverables. Key responsibilities include developing and maintaining study‑specific TMF documents such as TMF Plans, TMF Indexes, and Expected Document Lists (EDLs), as well as managing system setup elements like countries, sites, personnel, and user access within the eTMF to ensure proper security and permissions. The role leads TMF storyboarding to ensure the file accurately reflects study activities, decisions, and key events. It also supports and oversees periodic TMF completeness reviews, ensuring they follow SOPs and that any issues are resolved promptly. Additional responsibilities include uploading documents, performing quality control and remediation, and managing queries as needed. The individual tracks key performance indicators (KPIs), prepares TMF status reports, and communicates metrics, trends, and issues to both the study team and TMF leadership, taking action when concerns arise. Participation in study meetings is required to provide TMF updates and guidance. This role also supports audits and inspections by assisting with preparation, execution, and follow‑up, including managing corrective action plans. It performs risk‑based quality checks, drives issue resolution, and proactively communicates risks, updates, and changes to stakeholders. In addition, the position promotes continuous improvement by capturing and sharing lessons learned and acting as a TMF advocate across programs. It involves onboarding and managing TMF Specialists (both employees and contractors), monitoring their performance, providing feedback, identifying training needs, and supporting their professional development. The role contributes to the creation and refinement of SOPs, tools, templates, and training materials, and may participate in system updates, including user acceptance testing and enhancement discussions. Staying current with TMF standards, industry best practices, and regulatory expectations is essential. Other duties may include supporting TMF leadership on broader initiatives and special projects as needed. Required Skills A bachelor’s degree in a science or healthcare‑related field is required. The role also requires 10–12 years of relevant experience in clinical operations within a biotechnology company, pharmaceutical organization, CRO, or TMF vendor setting. This includes at least 9 years of hands‑on experience in TMF management and working with eTMF systems, with strong preference for experience using Veeva Vault eTMF. Candidates should be proficient in Microsoft Excel, Word, and PowerPoint, and have working knowledge of tools such as Smartsheet and SharePoint. A solid understanding of the clinical trial lifecycle and experience managing clinical trial documentation are essential. Prior experience managing direct reports is required, along with a strong understanding of the TMF Reference Model. The candidate must also demonstrate knowledge of and adherence to ICH‑GCP guidelines, and Good Documentation Practices. #J-18808-Ljbffr The University of Texas MD Anderson Cancer Center