TMF Operations Specialist - Remote & Audit-Ready

Alimentiv 2; Warszawa; On-site; PLN 60,000 - 90,000; Full time

Job summary

Alimentiv seeks a TMF Associate to manage Trial Master File content across the study lifecycle. You will ensure TMF is complete, inspection ready, and aligned with study timelines while collaborating with cross-functional teams and stakeholders.

Home-based with occasional office visits, you will support TMF governance and process improvements. The role requires a college degree and 1–3 years of TMF-related experience, with grounding in ALCOA and strong problem-solving skills.

Qualifications

• The successful candidate will possess a college diploma/degree and 1-3 years of relative related experience or ongoing 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.

Responsibilities

• 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 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 applying ALCOA principles appropriately.
• File and retrieve TMF documents in a timely manner.
• Complete routine administrative tasks in a timely manner (e.g., timesheets, metrics).
• Participate in discussions and meetings; share knowledge within the department.
• Support development and maintenance of internal systems (e.g., TMF databases).
• Provide mentorship and training to junior staff.
• Suggest improvements to department quality system documents to boost efficiencies.

Skills

Time management

Problem solving

Communication

Cross-functional collaboration

Education

College diploma/degree

Tools

Microsoft Office Suite

Microsoft Excel

Job description

Alimentiv seeks a TMF Associate to manage Trial Master File content across the study lifecycle. You will ensure TMF is complete, inspection ready, and aligned with study timelines while collaborating with cross-functional teams and stakeholders.

Home-based with occasional office visits, you will support TMF governance and process improvements. The role requires a college degree and 1–3 years of TMF-related experience, with grounding in ALCOA and strong problem-solving skills.