TMF Associate

Alimentiv is seeking a dedicated TMF Associate to join our TMF Operations team. In this role, you will be responsible for the comprehensive management of Trial Master File content and associated processes throughout the entire study lifecycle, ensuring that all documentation remains complete and inspection-ready.

Key responsibilities

• Serve as the primary point of contact for TMF management on assigned studies.
• Ensure all documents are filed contemporaneously and maintain the TMF in an inspection-ready state.
• Develop and maintain study-specific TMF management plans, expected document lists, and file indexes.
• Perform periodic quality control inventories to ensure completeness and address any findings.
• Provide TMF training to internal and external stakeholders and resolve TMF help desk tickets.

Requirements

• College diploma or degree with 1-3 years of relevant experience in TMF organization and implementation.
• Strong understanding of TMF regulations, guidance, and the application of ALCOA principles.
• Proven ability to identify challenges and proactively implement effective solutions.
• Excellent time management skills and demonstrated computer literacy, including proficiency in Microsoft Office.
• Ability to work effectively within a cross-functional team and foster a professional, collaborative environment.

What we offer

• Opportunity to work in a fully remote environment within a global organization.
• Professional development through mentorship and participation in department quality system improvements.
• Engagement in a supportive team culture that values knowledge sharing and continuous learning.