Opportunity at
AlimentivTMF Associate
Alimentiv is hiring a full-time, permanent TMF Associate to manage Trial Master File content and processes throughout the study life cycle. This home-based role, which requires…
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About This Role
Alimentiv is hiring a full-time, permanent TMF Associate to manage Trial Master File content and processes throughout the study life cycle. This home-based role, which requires the ability to go into the office occasionally, involves acting as the primary TMF contact for assigned studies to ensure documentation remains complete and inspection-ready. The position suits professionals with organizational skills and a background in file management who can collaborate within cross-functional teams.…
Job Description
Alimentiv is hiring a full-time, permanent TMF Associate to manage Trial Master File content and processes throughout the study life cycle. This home-based role, which requires the ability to go into the office occasionally, involves acting as the primary TMF contact for assigned studies to ensure documentation remains complete and inspection-ready. The position suits professionals with organizational skills and a background in file management who can collaborate within cross-functional teams.
Key duties include maintaining electronic file repositories, conducting periodic inventories, reconciling expected document lists, and resolving help desk tickets. The TMF Associate will also design study-specific management documents, provide training to stakeholders, apply ALCOA principles, and support internal quality systems and junior staff mentorship.
Responsibilities
- Manage TMF content and associated processes from study setup through transfer and archiving
- Serve as the primary TMF contact for assigned studies and ensure files are complete and inspection-ready
- Collaborate with Team Leaders to create study-specific management and oversight documents
- Maintain a quality control schedule and execute periodic inventories of study TMFs
- Identify and communicate incomplete or out-of-scope documents to study teams and escalate when necessary
- Reconcile expected document lists based on study milestones and events
- Prioritize, triage, and resolve TMF help desk tickets
- Deliver TMF training to internal and external stakeholders
- Process, review, file, and retrieve documents following scanning best practices and ALCOA principles
- Complete administrative duties such as timesheets and metrics
- Contribute to department meetings, working groups, and quality system document development
- Provide training and mentorship to junior staff members
Requirements
- Possess a college diploma or degree along with three years of related experience, or equivalent ongoing training
- Demonstrate an understanding of TMF organization, implementation, archival, and relevant regulations
- Apply ALCOA principles to TMF oversight
- Utilize time management and problem-solving skills
- Show computer literacy and functional knowledge of Microsoft software packages
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote or on-site?
The posting states the role is home-based, with the ability to go into the office occasionally if needed.
What is the employment type?
The position is full-time and permanent.
What qualifications are required for the TMF Associate role?
Candidates must possess a college diploma or degree with three years of relative experience or ongoing training, familiarity with TMF regulations, problem-solving skills, and Microsoft package literacy.
What is the salary for this position?
The salary is not specified in the job posting.
Who does the TMF Associate report to?
The role reports to the Manager of TMF Operations.
Sample Interview Questions
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