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.