TMF Operations Associate – Remote Archive & Compliance

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

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