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.