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