Sr. TMF Specialist - Contract

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. Originally posted on Himalayas