Job Description

The TMF Manager provides advanced leadership in Trial Master File (TMF) strategy and operations, independently guiding complex studies and ensuring excellence in TMF management. This role serves as a key escalation and decision-making point between study teams and TMF Operations, driving alignment and timely resolution. The TMF Manager strengthens organizational capability by fostering proactive issue management and promoting cross-functional collaboration to support the successful delivery of clinical studies.
###

Key Role Responsibilities

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.
###

Qualifications

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.

PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain "@alimentiv.com", to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender's email address and that they are asking you to apply on this website. If you believe you've been a victim of a phishing scam, please contact your local government cyber authority to report.Accommodations are available for applicants with disabilities upon request throughout the recruitment lifecycle


We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.