Job Details
Posted 22 April, 2026
Job Id: 627363
Manager, TMF Management & Oversight
Job Description
JOB DESCRIPTION
Manager, TMF Management & Oversight
The Manager, Trial Master File (TMF) is a hands-on TMF Subject Matter Expert (SME) responsible for executing, maintaining, and continuously improving the quality and compliance of the TMF across clinical studies. This role combines operational ownership with SME-level expertise, ensuring a complete, accurate, and inspection-ready TMF in alignment with ICH-GCP and global regulatory requirements.
This position partners closely with Clinical Operations, Clinical Sub-Team (CST) members, and external vendors, and serves as a primary driver of TMF quality, execution, and inspection readiness.
Key Responsibilities
* Act as a hands-on TMF SME, actively managing TMF activities across the study lifecycle (start-up, maintenance, and closeout)
* Execute and maintain end-to-end TMF oversight (internally and externally managed eTMF), ensuring quality and compliance–not just governance
* Ensure TMF completeness, accuracy, and timeliness in accordance with ICH-GCP, TMF Reference Model, and internal SOPs
* Perform and lead ongoing TMF quality control (QC), quality review (QR), reconciliation, and completeness reviews
* Drive TMF health metrics, identify gaps, and implement corrective and preventive actions (CAPAs)
* Maintain continuous inspection readiness and actively support regulatory inspections and audits (preparation, conduct, and follow-up)
* Serve as eTMF system SME, including hands-on support with configuration, taxonomy, metadata, and user adoption
* Participate in system enhancements and releases (requirements, UAT scripting/testing, release reviews)
* Author and maintain TMF documentation (e.g., TMF Management Plans, content lists, process documents, training materials)
* Lead TMF reconciliation activities with internal teams, CROs, and vendors
* Manage and oversee CRO/vendor TMF deliverables, ensuring adherence to standards and timelines
* Drive continuous process improvement to enhance TMF quality, efficiency, and compliance
* Support TMF migrations, system implementations, and vendor transitions
* Act as the primary TMF point of contact for assigned studies
* Provide hands-on training, mentorship, and guidance to team members and study partners
* Contribute to TMF standards, governance, and best practices, with a focus on execution and quality
Qualifications
* 5-8+ years of direct, hands-on TMF/eTMF experience in clinical research (execution-focused, not solely oversight)
* Demonstrated expertise in TMF quality management, QC/QR, reconciliation, and inspection readiness
* Strong knowledge of ICH-GCP, TMF Reference Model, and global regulatory requirements
* Hands-on experience with eTMF systems (e.g., Veeva Vault TMF or equivalent), including metadata and document management practices
* Proven ability to identify TMF gaps and drive resolution independently
* Experience working with CROs and vendors on TMF deliverables and quality
* Strong organizational skills with the ability to manage multiple studies in a fast-paced environment
* Effective cross-functional collaboration and stakeholder influence
* Excellent analytical, problem-solving, and communication skills
Education
* Bachelor’s degree in Life Sciences, Health Sciences, or related field required
* Advanced degree preferred
Pay range: 40-51/hr *based on expereincce
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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