Job Description

Accountabilities

• Perform TMF Approver and/or TMF QC Reviewer activities in accordance with applicable Standard Operating Procedures (SOPs) and established working practices.
• Process, review, classify, and resolve rejected Trial Master File documents across complex clinical studies and sponsor portfolios.
• Manage essential documents in both electronic and hard-copy formats while maintaining accurate records and consistent document standards.
• Prepare periodic TMF Quality Control checklists and coordinate their review with relevant project team members.
• Conduct periodic TMF quality control activities to verify compliance with regulatory requirements, ICH GCP principles, sponsor expectations, SOPs, and industry best practices.
• Work with electronic document management repositories and eTMF systems to review, index, process, and maintain essential clinical trial documentation.
• Apply standardized document naming conventions and indexing requirements to ensure records are complete, accurate, searchable, and inspection-ready.
• Collaborate regularly with project teams and colleagues across functions and geographies to resolve documentation issues and support efficient TMF processes.
• Maintain high standards of accuracy while managing multiple detailed activities within established timelines.

Requirements:

• University degree preferred, ideally in Life Sciences or a related discipline.
• Up to 1–2 years of relevant experience in TMF operations, records management, clinical research, CRO, pharmaceutical, or a related environment.
• General understanding of clinical research principles, clinical trial processes, and the purpose of Trial Master Files.
• Experience or demonstrated ability in data collection, indexing, document editing, and applying standardized naming conventions.
• Ability to work effectively with electronic document repositories, eTMF platforms, or similar document management systems, with willingness to develop further technical proficiency.
• Strong written and verbal communication skills, with the ability to present information clearly, accurately, and concisely.
• Exceptional attention to detail and accuracy when handling highly structured and sensitive documentation.
• Strong planning, prioritization, and organizational skills, with the ability to manage multiple tasks in a deadline-driven environment.
• Proficiency with Microsoft Word and Excel.
• Strong interpersonal and collaboration skills, with the ability to work effectively in a fast-paced, changing, and globally distributed environment.
• A proactive, reliable, and quality-focused approach to work, with a commitment to following procedures and maintaining compliance.

Benefits:

• Opportunity to build specialized experience in TMF operations and clinical research within a global CRO environment.
• Exposure to international clinical studies, sponsor portfolios, project teams, and industry best practices.
• Hands-on experience with electronic TMF and document management technologies.
• Opportunities to collaborate with experienced professionals across clinical research and project teams.
• A supportive and inclusive working environment that values collaboration, creativity, and professional development.
• Career development opportunities within a global organization focused on improving clinical research and patient outcomes.
• An environment committed to equal opportunity, diversity, inclusion, and respectful collaboration.
• Meaningful work contributing to the quality, compliance, and integrity of clinical trials that can ultimately improve patients' lives.