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Biomea FusionSr. TMF Specialist - Contract
Biomea Fusion is looking for a Sr. TMF Specialist to join the organization on a contract basis lasting approximately six months. This role centers on managing…
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About This Role
Biomea Fusion is looking for a Sr. TMF Specialist to join the organization on a contract basis lasting approximately six months. This role centers on managing the daily operations of the Trial Master File system and assisting with related documentation tasks. The professional chosen for this assignment will coordinate with contract research organizations, vendors, and internal departments to maintain document compliance and readiness. Key duties involve uploading files, executing quality…
Job Description
Biomea Fusion is looking for a Sr. TMF Specialist to join the organization on a contract basis lasting approximately six months. This role centers on managing the daily operations of the Trial Master File system and assisting with related documentation tasks. The professional chosen for this assignment will coordinate with contract research organizations, vendors, and internal departments to maintain document compliance and readiness.
Key duties involve uploading files, executing quality control procedures, managing user permissions, and generating weekly status reports to resolve quality concerns. This position also requires leading completeness verifications, reviewing expected document lists, conducting periodic quality reviews, and supporting file reconciliations, transfers, and archiving. Additionally, the specialist will collaborate with content owners, contribute to inspection readiness efforts, and participate in audits.
This opportunity is well-suited for an independent professional with extensive trial master file experience who can manage priorities effectively in a dynamic setting.
Responsibilities
- Upload files into the Trial Master File system
- Perform quality control checks on system documents
- Grant and revoke system user permissions
- Distribute weekly reports to address open quality concerns promptly
- Manage periodic functional quality control review cycles
- Lead completeness checks and verify expected document list accuracy
- Take part in oversight reviews for contractor-managed master files
- Assist with file reconciliations
- Manage master file activities as required
- Oversee file transfers and archiving
- Collaborate directly with content owners across functional areas
- Participate in audits and support inspection readiness tasks
- Coordinate with external vendors, contract research organizations, and cross-functional teams to meet documentation standards
Requirements
- At least five years of relevant Trial Master File experience
- Ability to work independently and prioritize tasks effectively
Qualifications
- Bachelor's degree from an accredited institution or equivalent practical experience
- Fundamental knowledge of organization tools and filing systems
- Familiarity with GCP, ICH, and CFR regulations
- Proficiency in Microsoft Word, Excel, PowerPoint, and SharePoint
- Acquaintance with the CDISC Trial Master File Reference Model framework
- Experience using Veeva Vault Clinical eTMF
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the employment type and duration?
This is a contract position intended to last for approximately six months.
What is the compensation for this role?
The expected pay rate is between $40 and $50 per hour, which is determined by the candidate's location and experience.
What experience is required to apply?
Applicants must have a minimum of five years of relevant Trial Master File experience, along with either a bachelor's degree or equivalent practical experience.
Sample Interview Questions
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