About this role
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.