A recognized California-based pharma company is actively seeking a new TMF Operations Specialist to join their team in a Remote capacity. In this role, the TMF Operations Specialist will be 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.
***This is a Remote opportunity; however, the qualified professional must reside within the North Bay Region of California area for ad-hoc on-site visits to the CA office for receipt, inventory review, and storage of TMF Final Transfers.***
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
Qualifications:
- 2+years of professional TMF document control experience
- Bachelor’s Degree or equivalent curriculum
- 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)
- Strong computer skills (MS Office), including exposure to data/document management systems
- Effective written/oral communication and interpersonal skills
- Good time management skills, excellent attention to detail, and the ability to multitask in a high-volume environment
Desired Skills:
- Bachelor’s Degree in Healthcare and/or a Science-related discipline
- Familiarity with international clinical trials, clinical trial documents, and document QC process
