TMF Study Administrator - Remote

Overview

The TMF Study Administrator provides expert support and analysis of the TMF, helping maintain the inspection readiness of clients’ Trial Master File (TMF) and promoting TMF health and best practices.

In Short

• Manage paper documents including filing and/or shipping.
• Process, upload, and index TMF documents.
• Track and maintain TMF documentation.
• Perform in-line document quality control.
• Support TMF set-up based on pre-defined structure.
• Run metrics reports and communicate output.
• Identify and share trends in metrics reports.
• Conduct TMF quality reviews and communicate findings.
• Support remediation projects and retrospective TMF reconciliation.
• Communicate with the study team on TMF-related matters.

Requirements

• 2 years relevant industry experience in Clinical or TMF Operations oversight.
• Excellent knowledge of document recognition and Good Documentation Practices (GDP).
• Familiar with eTMF systems and Clinical Trial Lifecycle.
• Aware of TMF Lifecycle and TMF stakeholders.
• Independent in verbal and written communication.
• Strong organizational skills and ability to prioritize.
• Foundation skills in external collaboration and negotiation.
• Ability to work under pressure and analyze information.
• Developing in coaching and mentoring.
• Understanding of TMF Management Plans and TMF Training.

Benefits

• Benefit offerings may vary by country and align with local market practice.
• Full-time position with opportunities for career growth.
• Supportive work environment focused on health and well-being.
• Commitment to equal employment opportunity and reasonable accommodations.
• Engagement in meaningful work that impacts health outcomes.