Hiring: TMF Lead Company: BioSpace Location: Malvern, PA Job Posted Time: 2026-09-10 10:36:35 Target Skills & Keywords : GCP, User Experience, Vault About the job Experience: •5-7 years of progressive clinical research experience in the biotechnology/pharmaceutical industry, with a significant focus on TMF operations/management. •7 years of progressive clinical research experience in the biotechnology/pharmaceutical industry, with a significant focus on TMF operations/management. Required Skills: •Lead and own TMF activities across assigned clinical studies from study startup through closeout and archival, ensuring TMF completeness, quality, and continuous inspection readiness at every phase of the trial, within the Veeva TMF (Vault) platform. •Serve as the primary TMF subject matter expert (SME) and go-to resource for study teams, Clinical Operations, Data Management, Regulatory Affairs, Biostatistics, Pharmacovigilance, and external CROs/vendors on all TMF-related questions, processes, and requirements. •Develop and maintain TMF management plans, filing strategies, and Expected Document List (EDL) configurations aligned to the DIA TMF Reference Model; review and monitor TMF metrics, KPIs, and quality indicators; perform routine TMF health checks and reconciliation activities. •Conduct TMF Quality Control (QC) reviews and periodic self-inspections; identify TMF risks, gaps, and misfiled or missing documents; drive root-cause analysis and implement corrective and preventive actions (CAPAs). •Maintain ongoing inspection readiness for all assigned studies; coordinate document retrieval and responses during sponsor audits and regulatory inspections (FDA, EMA, MHRA, and other health authorities); lead TMF remediation activities and inspection preparation exercises. •Ensure compliance with ICH-GCP (E6(R2)/(R3)), applicable FDA/EMA/MHRA regulations, and company SOPs governing TMF content, completeness, and timeliness throughout the trial lifecycle. •Configure and administer the Veeva Vault eTMF system for assigned studies, including user access/role management, metadata and document classification, workflow configuration, and support for system upgrades, migrations, or implementation projects. •Partner with Clinical Operations, CRAs, and CRO/vendor TMF counterparts to ensure timely, accurate transfer and filing of site, vendor, and trial-level documents; reconcile CRO-held TMF content against the Expected Document List and the company TMF. Qualifications: •Bachelor's degree in life sciences or a related field; advanced degree a plus. •Hands-on experience managing TMF from study startup through closeout and archival, including direct experience with the Veeva Vault eTMF system (required). •Solid functional working knowledge of the DIA TMF Reference Model (TMF RM) and Expected Document List (EDL) management. •Strong knowledge of ICH-GCP, FDA, EMA, MHRA, and other applicable global regulatory requirements governing TMF content and inspection readiness. •Demonstrated experience supporting sponsor audits and/or regulatory inspections, including TMF remediation. •CRO/vendor management experience, including oversight of TMF-related deliverables. •Demonstrated ability to work independently and resourcefully in a small biotech with competing priorities and limited resources. •Excellent cross-functional communication and collaboration skills; proven ability to serve as an SME and trusted go-to resource. •Outstanding attention to detail, organizational skills, and document/records management discipline. •Self-motivated with a strong commitment to quality, accuracy, and on-time deliverables. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!