Clinical TMF Operations Administrator

Responsibilities

• Lead TMF activities for assigned trials across start-up, maintenance, close-out, and archive phases, ensuring consistent communication with Clinical Trial Teams (CTT) and CRO partners.
• Oversee implementation and maintenance of processes for cataloging, filing, retrieval, storage, preservation, and protection of TMF records (electronic and paper) and CTMS outputs.
• Manage e TMF health by overseeing Quality Issue (QI) workflows, ensuring timely remediation of QC/QR findings, including closing or reassigning QIs as appropriate.
• Govern Expected Document Lists (EDL), including completeness, accuracy, and reconciliation of document counts in collaboration with CTT and CRO teams.
• Monitor compliance with TMF business processes and escape risks or non-compliance to Clinical Operations and Quality leadership as needed.
• Deliver scheduled and ad hoc TMF health metrics, analysis, and insights to support trial teams and leadership decision-making.
• Ensure TMF inspection readiness through ongoing quality oversight, including ad hoc QC reviews of uploaded documents and maintenance of filing/naming conventions aligned with the TMF Reference Model.
• Provide subject matter expertise (SME) for audits and inspections, including preparation, support, and remediation activities.
• Maintain current knowledge of regulatory requirements, TMF Reference Model standards, and industry best practices.
• Support TMF document processing, including filing oversight, troubleshooting, and responding to TMF-related inquiries.
• Participate in trial-specific and departmental meetings, providing TMF expertise and status updates.
• Perform general operational and administrative activities to support assigned trials.
• Contribute to TMF strategy, planning, and continuous improvement initiatives, including development of processes, tools, and training for TMF stakeholders.
• Support Clinical Operations leadership on high-impact projects and organizational initiatives.
• Supervise TMF operations, proactively identify risks, anticipate challenges, and implement mitigation strategies to ensure delivery of team and project goals.
• Core Competencies

Demonstrates expertise in TMF activities, including e TMF document management, compliance with regulatory requirements, and quality oversight.

Proven ability to lead cross-functional collaboration, implement process improvements, and deliver actionable insights for clinical trial teams.

Requirements

• A bachelor’s degree in a related discipline and 4+ years’ work experience, preferably in a relevant clinical research setting.
• 2-3+ years’ experience in e TMF document management (in a specialized team or as a member of a clinical trial team) is an advantage.
• Strong organizational/prioritization skills for the management of workload and attention to detail.
• Strong experience collaborating with the DIA (CDISC) TMF Reference Model.
• Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.
• Experience leading or overseeing TMF operations, including cross-functional collaboration with Clinical Trial Teams, CROs, and vendors.
• Ability to influence stakeholders, escape risks appropriately, and drive accountability across teams.
• Experience generating and interpreting TMF health metrics and analytics to inform decision-making and improve performance.
• Demonstrated success in process improvement, SOP development, and TMF strategy implementation.
• Excellent organizational and prioritization skills with strong attention to detail.
• Proactive, solution-oriented mindset with ability to anticipate risks and implement mitigation strategies.
• Strong communication skills, with the ability to present insights and recommendations to both operational teams and leadership.
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