TMF Operations Specialist

Overview TMF Operations Specialist – Full-time – Contract Duration: 4 Months Location: Novato, California 94949 (HYBRID) Job Description This position is responsible for the maintenance, quality review, transfer, closure and archival of Sponsor Trial Master File (TMF) essential documentation in accordance with regulatory requirements and standards of Good Clinical Practice (GCP), International Conference on Harmonization Regulations (ICH) E6 (R3), and European Union (EU) regulations/directives, and Client Standard Operating Procedures (SOPs) as appropriate. The TMF Operations Specialist will provide support to TMF content owners on one or more clinical programs. This role serves as a pivotal point of contact and works closely with internal Study Management Teams (SMTs) and external CROs/Vendors to ensure that the TMF is complete, accurate, contemporaneous, and inspection-ready according to Client TMF SOPs and TMF Plans. Responsibilities Perform quality checks of TMF document submissions (uploads) for approval, identify and assign any quality issues (QIs), and follow-up for action completion and QI resolution Ensure TMF documentation follows the requirements outlined in study-specific TMF Plans and Indices including document classification, expectedness, filing level, naming conventions, metadata assignment, responsibility, and filing locations Track periodic and final review intervals and provide TMF full reports/inventories for study team review; verify review completion and QI resolution and issue TMF periodic and final review completion certificates Support TMF final transfer activities for the receipt, review, acceptance, and archival of TMF transfers from external CROs/Vendors Attend TMF Operations and SMT meetings regularly and provide updates on TMF performance, status updates, trends in identified quality issues, risk mitigations, and outstanding/open quality issues Work cross-functionally with internal departments and external resources (e.g., CROs, Partners) to resolve gaps for a study TMF Requirements This position is remote-based, but candidates must reside within the Novato, CA area for ad-hoc on-site visits to the Novato office for receipt, inventory review, and storage of TMF Final Transfers Bachelor’s degree or equivalent in a scientific or healthcare discipline preferred, with a minimum of 2 years of professional TMF document control experience Experience with electronic trial master file systems (Veeva Vault eTMF), workflows, configurations, feature/functionality, and industry best practices for business process alignment Advanced knowledge of ICH/GCP Regulations, GDP and ALCOA+ requirements, CDISC Reference Model, and industry best practices Knowledge of Sponsor TMF regulatory requirements and an understanding of Good Documentation Practices (GDP) Familiarity with international clinical trials, clinical trial documents, and document QC process Ability to work under general supervision with guidance; able to collaborate with Manager to establish priorities and timelines Strong computer skills (MS Office) including experience with data/document management systems EEO and Administrative Information Innova Solutions is an Equal Opportunity Employer and prohibits unlawful discrimination and harassment. If you require a reasonable accommodation to assist with your job search or application, please contact View email address on click.appcast.io. Innova Solutions encourages all qualified candidates to apply for employment opportunities. This description includes information related to the role, responsibilities, requirements, and benefits as applicable. #J-18808-Ljbffr MassGenics