TMF Associate

Role overview

The TMF Associate will oversee Trial Master File (TMF) content and the related workflows across the full study journey, from study setup through transfer and archival. This role partners closely with study teams to support periodic file reviews and audits, resolve TMF-related findings, and maintain a controlled electronic repository with the proper file structure and access controls. The position calls for strong cross-functional collaboration, clear communication, and a professional, solution-oriented approach. Time allocation may be adjusted based on business needs.

This is a permanent full-time position reporting to the Manager, TMF Operations within the TMF Operations department.

There are 2 openings for this role. The position is cross-listed in multiple countries.

Service delivery

• Act as the main TMF point of contact for assigned studies.
• Keep the TMF complete and ready for inspection throughout the study lifecycle, ensuring records are filed as they are generated.
• Partner with the Team Lead to prepare study-specific TMF governance documents such as the file index, expected document list, and TMF management plan in line with study needs.
• Create and update study-specific work instructions when required.
• Maintain a quality-control schedule and complete periodic TMF inventories to confirm completeness.
• Review incomplete or out-of-scope documents, communicate issues to study teams, and escalate when necessary.
• Reconcile expected document lists in response to study events and milestones.
• Prioritize and resolve TMF help desk requests, including triage when needed.
• Deliver study-specific TMF training to internal and external stakeholders as required.
• Process, scan, review, file, and retrieve TMF documents promptly while following applicable scanning standards and ALCOA principles.

Department support

• Complete routine administrative work on time, including timesheets and metrics.
• Contribute to department meetings, discussions, presentations, and smaller working groups by sharing knowledge and participating in decisions.
• Look for opportunities to support the development, implementation, and upkeep of internal systems such as records-management databases.
• Provide coaching and training to junior colleagues.
• Recommend improvements and contribute to department quality system documents that improve efficiency.

Qualifications

A college diploma or degree is required, along with 1 to 3 years of relevant experience or ongoing training. The successful candidate should understand TMF organization, implementation, and archiving, including the regulations and guidance that help maintain TMF quality and integrity. Familiarity with ALCOA principles in TMF oversight is important, along with solid time management and problem-solving ability. The role also requires the initiative to identify challenges and propose solutions, as well as strong computer literacy and practical knowledge of Microsoft applications with the ability to build on those skills.

Working conditions

• The role is home-based, with occasional office visits if needed.
• Accommodation for candidates with disabilities is available throughout the recruitment and selection process on request.

Warning and additional information

• The company warns applicants about phishing scams using fake communication channels. Official candidate communication will only come from email addresses ending in @alimentiv.com. Applicants should verify the sender domain and any request related to the application process. Suspected scams should be reported to the appropriate local cyber authority.
• The organization may use artificial intelligence tools at certain stages of hiring, such as screening applications, reviewing resumes, or checking responses for inconsistencies or verification signals. These tools support the recruitment team but do not replace human judgment, and final hiring decisions are made by people. Applicants may contact the company for more information about data processing.