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