TMF Operations Specialist

Innova Solutions•Sacramento, CA

3d•Hybrid

About The Position

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 principles 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 the TMF content owners on one or more clinical programs. This position 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.

Requirements

This position is remote based, but candidates must reside within the Novato, CA area for ad-hoc on-site visits to the Novato, CA office for receipt, inventory review, and storage of TMF Final Transfers.
Bachelor’s degree or equivalent curriculum (scientific or healthcare discipline preferred) and 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
Demonstrated knowledge of Sponsor TMF regulatory requirements and an understanding of the range of working procedures relating to it, together with an understanding of Good Documentation Practices (GDP)
Familiarity with international clinical trials, clinical trial documents, and document QC process highly desirable
Works under general supervision and guidance.
Works with Manager to establish priorities and timelines
Strong computer skills (MS Office) including exposure to data/document management systems.

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 but not limited to document classification, expectedness, filing level, naming conventions, metadata assignment, responsibility, filing locations, etc.
Track periodic and final review intervals and provide TMF full report/inventories for study team review performance; verify review completion and quality issue (QI) resolution and issue TMF periodic and final review completion certificate(s)
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 SMT 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, etc.) to resolve gaps for a study TMF