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.