Sr. TMF Specialist - Contract

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. TMF Specialist - Contract based in United States. This is a senior-level Clinical Operations opportunity focused on maintaining the operational integrity, quality, and organization of the Trial Master File (TMF). You will manage critical TMF activities including document uploads, quality control, access management, completeness checks, reconciliations, transfers, and archival. The role plays an important part in ensuring trial documentation remains accurate, complete, inspection-ready, and aligned with applicable TMF expectations. You will work closely with functional content owners, CROs, vendors, and cross-functional teams to resolve quality issues and maintain consistent documentation standards. The position also provides exposure to audits, inspection readiness, CRO-owned TMFs, and periodic functional quality reviews. This is a fully remote contract role for approximately six months, offering an opportunity to contribute independently within a clinical development environment. The ideal candidate is organized, detail-oriented, knowledgeable in TMF practices and regulations, and comfortable taking ownership of time-sensitive documentation activities.

Upload and maintain clinical trial documents within the Trial Master File system. Perform quality control reviews of TMF documents to ensure accuracy, completeness, and adherence to applicable standards. Grant and revoke user access in accordance with established TMF processes and requirements. Prepare and distribute weekly reports to support the timely resolution of outstanding quality issues. Own periodic TMF Functional QC Review cycles and coordinate follow-up activities. Lead TMF completeness checks and ensure Expected Document Lists (EDLs) remain accurate and current. Participate in oversight reviews of CRO-owned TMFs and support reconciliation activities as required. Manage additional TMF activities and documentation processes according to operational needs. Oversee TMF transfers and support TMF archival activities when required. Work directly with functional-area content owners to ensure required documentation is captured and maintained appropriately. Participate in audits and contribute to inspection readiness activities. Partner with CROs, vendors, and cross-functional stakeholders to promote adherence to TMF expectations and documentation standards. Identify and address documentation gaps, quality issues, and process inconsistencies in a timely manner. Work independently, prioritize competing TMF activities, and maintain reliable delivery against deadlines. Requirements: Bachelor’s degree from an accredited institution or equivalent practical experience. 5+ years of relevant Trial Master File (TMF) experience. Fundamental understanding of filing systems, document management, and organizational tools. Knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable CFR regulations. Familiarity with the CDISC Trial Master File Reference Model structure. Experience with Veeva Vault Clinical/eTMF is preferred. Proficiency with Microsoft Office applications, particularly Word, Excel, PowerPoint, and SharePoint. Strong attention to detail and commitment to document quality and accuracy. Ability to work independently, manage priorities, and meet deadlines in a remote environment. Strong communication and collaboration skills for working with CROs, vendors, content owners, and cross-functional teams. Comfortable supporting audits, inspection readiness, quality reviews, and documentation remediation activities. Benefits: $40–$50 per hour, depending on experience and location. Approximately 6-month contract opportunity. Fully remote position based in California. Senior-level ownership of operational TMF activities within Clinical Operations. Exposure to TMF quality control, completeness, reconciliation, transfer, and archival processes. Collaboration with CROs, vendors, functional teams, and clinical operations stakeholders. Experience supporting audits and inspection readiness. Opportunity to work with Veeva Vault Clinical/eTMF and CDISC TMF Reference Model practices. Hands-on experience within a clinical development and regulated GCP environment.