Position Summary:

Biomea Fusion is hiring a TMF Administrator who will be responsible for maintaining the operational aspects of the TMF system and supporting TMF-related activities.

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
• Participating in Periodic TMF Functional QC Review cycles
• Participating in 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
• Supporting management with TMF activities as needed
• Supporting 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

Education Requirement:

• Bachelor’s degree from an accredited institution or equivalent practical 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 (preferred)
• Experience with Veeva Vault Clinical (eTMF) and WingSpan

Industry:

• Biotechnology

Employment Type:

• Consultant

Equal Employment Opportunity:

At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. 

The expected rate for this role is $___ to $_____, dependent on experience.