Maintains the Trial Master File system by uploading and quality-checking documents, managing access, resolving quality issues, conducting completeness and functional QC reviews, and supporting reconciliations, transfers, archival, audits, and inspection readiness. Partners with CROs, vendors, and cross-functional stakeholders to ensure TMF compliance and accuracy.
Position Summary:
Biomea Fusion is hiring a Sr. TMF Specialist, who will be responsible for maintaining the operational aspects of the TMF system and supporting TMF-related activities. This is a contract position for approximately 6 months.
Essential Responsibilities:
- Uploading documents into the TMF
- Performing QC of the documents in the TMF
- Granting/Revoking User Access
- Sending out weekly reports to ensure timely resolution of any outstanding Quality Issues
- Owning Periodic TMF Functional QC Review cycles
- Leading Completeness Checks and ensuring accuracy of the Expected Document Lists (EDLs)
- Participating in Oversight Reviews of CRO-owned TMFs
- Assisting in TMF Reconciliations as needed
- Management of TMF activities as needed
- Overseeing the transfer of TMFs as needed
- Supporting the archival of TMFs as needed
- Working directly with functional area content owners as needed
- Participating in audits and assisting with inspection readiness activities as needed
- Partnering with CROs, vendors, and cross-functional groups to ensure adherence to TMF expectations
Education Requirement:
- Bachelor’s degree from an accredited institution or equivalent practical experience.
- At least 5 years of relevant TMF experience.
Preferred Skills:
- Fundamental understanding of filing systems and organization tools
- Knowledge and understanding of GCP/ICH and CFR Regulations
- Proficiency with Microsoft Office Products - Word, Excel, Powerpoint, Sharepoint
- Familiarity with the CDISC Trial Master File Reference Model structure
- Experience with Veeva Vault Clinical (eTMF)
- Ability to work independently and prioritize tasks
Compensation:
The expected compensation rate is $40 to $50 per hour, dependent on experience and location.
Biomea Fusion Downtown Redwood City, California, USA Office
900 Middlefield Rd, 4th Floor, Downtown Redwood City, California, United States, 94063
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