TMF Associate

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

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 set up to transfer/archiving. Work in partnership with study teams during periodic file reviews and audits to address findings related to the TMF. Manage access and organization of the controlled electronic file repository, in line with the defined file structure and access management framework. Work proactively and successfully within a cross-functional team. Communicate and promote department and company 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

• Serve as the primary TMF contact for assigned studies.
• Ensure TMF is complete and "inspection ready" throughout study lifecycle and documents are filed contemporaneously.
• Work with Team Lead to 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 maintain study-specific work instructions, as needed.
• Utilize organization skills to maintain a quality control schedule and perform periodic inventories of study TMF to ensure completeness.
• Review and communicate out-of-scope and/or incomplete documents to study teams; escalating as needed.
• Reconcile expected document lists based on study events and milestones.
• Prioritize and resolve TMF help desk tickets; may include triaging activities.
• Provide study specific TMF training to internal and/or external stakeholders, as needed.
• Process and review documents, following applicable scanning and best practices and best practices, and applying ALCOA principles appropriately.
• File and 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