Remote TMF Operations Specialist

Visa Hunt; Poland; Hybrid; PLN 42,000 - 60,000; Full time

Job summary

Visa Hunt is seeking a TMF Associate to manage Trial Master File content throughout the study lifecycle, from setup through archiving, collaborating with study teams to address findings and ensure an inspection-ready TMF.

The role involves maintaining the controlled document repository, developing study-specific TMF procedures, training stakeholders, and resolving TMF tickets while upholding ALCOA principles and strong organizational standards.

Qualifications

• Candidate has a college diploma/degree with 1-3 years of related TMF experience or ongoing training.
• Understanding of TMF organization, implementation, and archival including relevant regulations to assure quality and integrity of TMFs.
• Ability to apply ALCOA principles to TMF oversight; strong time management and problem-solving.
• Demonstrated computer literacy and proficiency with Microsoft packages.

Responsibilities

• Serve as the primary TMF contact for assigned studies and ensure TMF is complete and inspection-ready.
• Create and maintain study-specific TMF management documents (e.g., File Index, TMF Management Plan) with study teams.
• Develop and refine study-specific work instructions and quality control schedules.
• Triaging and resolving TMF tickets; communicating issues to study teams and escalating when needed.
• Provide TMF training to stakeholders and ensure timely filing and retrieval of TMF documents.

Skills

ALCOA knowledge

Time management

Problem solving

MS Office

TMF oversight

Education

College diploma/degree

Tools

Microsoft Office

Job description

Visa Hunt is seeking a TMF Associate to manage Trial Master File content throughout the study lifecycle, from setup through archiving, collaborating with study teams to address findings and ensure an inspection-ready TMF.

The role involves maintaining the controlled document repository, developing study-specific TMF procedures, training stakeholders, and resolving TMF tickets while upholding ALCOA principles and strong organizational standards.