Remote TMF Associate — Trial Master File Expert

Alimentiv; Greater London; Remote; GBP 30,000 - 42,000; Full time

Job summary

Alimentiv is seeking a TMF Associate to manage Trial Master File content across the study lifecycle from setup to archiving. You will work with study teams during reviews and audits to address TMF findings and ensure controlled electronic file repositories are organized per policy.

You will help develop TMF management documents, maintain quality controls, and train staff as needed while partnering with the TMF Operations team to promote department and company goals.

Qualifications

• College diploma/degree; 1-3 years related experience or ongoing training.
• Understanding of TMF organization, implementation and archival including relevant regulations and guidance.
• Ability to apply ALCOA principles to TMF oversight; strong time management and problem-solving skills.

Responsibilities

• Serve as the primary TMF contact for assigned studies.
• Ensure TMF is complete and inspection-ready throughout the study lifecycle.
• Create study-specific TMF management documents (e.g., File Index, Expected Documents lists) in alignment with the study.
• Develop and maintain study-specific work instructions as needed.
• Maintain a quality control schedule and perform periodic TMF inventories for completeness.
• Review and escalate out-of-scope or incomplete documents to study teams as needed.
• Reconcile expected document lists based on study events and milestones.
• Prioritize and resolve TMF help desk tickets; triage as needed.
• Provide TMF training to internal/external stakeholders.
• File and retrieve TMF documents promptly.

Skills

Time management

Problem-solving

Microsoft Office

ALCOA principles

Documentation

Education

College diploma/degree

Tools

Microsoft Office

Job description

Alimentiv is seeking a TMF Associate to manage Trial Master File content across the study lifecycle from setup to archiving. You will work with study teams during reviews and audits to address TMF findings and ensure controlled electronic file repositories are organized per policy.

You will help develop TMF management documents, maintain quality controls, and train staff as needed while partnering with the TMF Operations team to promote department and company goals.