TMF Manager

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🕒 October 27, 2025

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Alimentiv

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

⚕️ Healthcare Insurance

🔬 Science

💊 Pharmaceuticals

Healthcare Insurance • Science • Pharmaceuticals

Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.

📋 Description

• Responsible for the strategic oversight and management of Trial Master File (TMF) operations across one or more complex clinical studies or programs. • Serves as the primary TMF operations lead for complex studies, providing strategic oversight and proactive issue resolution across study teams. • Demonstrates strong expertise in eTMF management systems, processes, and compliance requirements, ensuring inspection readiness and operational excellence throughout the study lifecycle. Key experience to look for would be experience within multiple eTMFs (either multiple systems or Veeva eTMF across multiple companies) • Partners effectively with cross-functional study management teams and external stakeholders to anticipate challenges, drive solutions, and maintain high-quality documentation. • Provides mentorship and guidance to Senior TMF Associates, fostering capability development and consistency across studies. • Partner with study and program teams to define TMF strategies, governance, and milestones aligned with study timelines.

🎯 Requirements

• 6–8 years of experience in clinical documentation or TMF operations within a CRO, sponsor, or pharma environment. • Proven experience managing or leading TMF activities for complex, global, or late-phase clinical studies.

🏖️ Benefits

• Accommodations are available for applicants with disabilities upon request throughout the recruitment lifecycle