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 TMFPerforming QC of the documents in the TMFGranting/Revoking User AccessSending out weekly reports to ensure timely resolution of any outstanding Quality IssuesOwning Periodic TMF Functional QC Review cyclesLeading Completeness Checks and ensuring accuracy of the Expected Document Lists (EDLs)Participating in Oversight Reviews of CRO-owned TMFsAssisting in TMF Reconciliations as neededManagement of TMF activities as neededOverseeing the transfer of TMFs as neededSupporting the archival of TMFs as neededWorking directly with functional area content owners as neededParticipating in audits and assisting with inspection readiness activities as neededPartnering 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 toolsKnowledge and understanding of GCP/ICH and CFR RegulationsProficiency with Microsoft Office Products - Word, Excel, Powerpoint, SharepointFamiliarity with the CDISC Trial Master File Reference Model structureExperience 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.