TMF Associate

Alimentiv; United States; Remote; USD 55,000 - 75,000; Full time

Job summary

Alimentiv is seeking a TMF Associate to manage Trial Master File content across the study life cycle, from setup to archiving. You will work with study teams to address TMF findings and ensure documentation is filed contemporaneously in a controlled repository.

The role emphasizes cross-functional collaboration, timely file reviews, and maintaining a quality control schedule. Home-based with occasional office visits, you will develop TMF management materials, train stakeholders, and promote

Qualifications

• College diploma/degree and 1–3 years of related experience or ongoing training.
• Understanding of TMF organization, implementation, and archival with regulatory awareness.
• Ability to apply ALCOA principles to TMF oversight.

Responsibilities

• Serve as the primary TMF contact for assigned studies.
• Ensure TMF is complete and inspection ready throughout the study lifecycle.
• Maintain study TMF oversight documents (File Index, lists, TMF plan).
• Develop and maintain study-specific work instructions as needed.
• Conduct periodic TMF inventories and quality checks.
• Escalate incomplete documents and communicate with study teams.
• Triages TMF tickets and provides training on TMF processes.
• File and retrieve TMF documents promptly.

Skills

ALCOA principles

Time management

Problem solving

MS Office proficiency

Education

College diploma/degree

Tools

Microsoft Office

Job description

Job Title:

TMF Associate

Employment Type:

Full time, Permanent

Job Reports To

Manager, TMF Operations

Department/Unit Name

TMF Operations

Job Summary:

Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study setup to transfer/archiving. Work in partnership with study teams during periodic file reviews and audits to address findings related to theTMF. Manage access and organization of the controlled electronic file repository, in line with the defined file structure and accessmanagement framework. Work proactively and successfully within a cross-functional team. Communicate and promote department andcompany goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses a professional and helpful attitude. Time allocated may be adjusted based on need.

Positions Available

2; Note this position is cross-listed in multiple countries.

Service Delivery

• Serveas the primary TMF contact for assigned studies.
• Ensure TMF is completeand “inspection ready” throughout study lifecycle and documents are filed contemporaneously.
• Work with Team Leadto create study specific TMF management and oversight documents (e.g., File Index, Expected Document Lists and TMF Management Plan) in alignment with study.
• Develop and maintainstudy-specific work instructions, as needed.
• Utilizeorganization skills to maintain a quality control schedule and perform periodic inventories of study TMF to ensure completeness.
• Review andcommunicate out-of-scope and/or incomplete documents to study teams; escalating as needed.
• Reconcile expecteddocument lists based on study events and milestones.
• Prioritizeand resolve TMF help desk tickets; may include triaging activities.
• Provide study specificTMF training to internal and/or external stakeholders, as needed.
• Process andreview documents, following applicable scanning and best practices and bestpractices, and applying ALCOA principles appropriately.
• Fileand retrieve TMF documents in a timely manner.

Department Support

• Complete routine administrative tasks in a timely manner (e.g., timesheets, metrics).
• Participate in discussions, decisions and sharing of knowledge in department meetings, periodic presentations, and smaller working groups.
• Seek opportunities to assist in the development, implementation and maintenance of internal systems (e.g., databases used to manage records).
• Provide mentorship and training to junior level staff.
• Propose suggestions and work on the development and maintenance of department quality system documents to improve efficiencies.

Qualifications

• The successful candidate will possess a college diploma/degree and 1-3 years of relative related experience or on going training. They will have an understanding of TMF organization, implementation, and archival including relevant regulations and guidance to assure quality and integrity of TMFs. Have the ability to incorporate the principles of ALCOA in relation to TMF oversight. Utilize skills in time management and problem-solving. Identify challenges and problems and take the initiative to identify solutions. Demonstrated computer literacy, proven functional knowledge of Microsoft packages and potential to develop.

Working Conditions

• Home based, with the ability to go into office occasionally if needed.
• *Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to [e-mail]