Trial Master Files Representative

Trial Master Files Representative

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Trial Master Files Representative based in United States.

This remote role supports the accurate preparation, organization, and maintenance of Trial Master Files (TMFs) for clinical research studies. You'll help ensure essential study documentation is complete, properly structured, indexed, and maintained according to sponsor expectations. The position offers the opportunity to work across clinical research teams, sponsors, project managers, monitors, study sites, and other stakeholders. Your attention to detail will directly contribute to regulatory readiness, study compliance, and high-quality document management. You'll operate in a collaborative environment where organization, communication, and reliability are essential to successful study delivery. The role is well suited to someone who enjoys structured work while managing multiple priorities in a fast-paced clinical research setting. It also provides an opportunity to deepen your expertise in clinical documentation and Trial Master File processes while working fully remotely.

Accountabilities

• Prepare and maintain Trial Master Files for internal and external clinical studies in accordance with sponsor-negotiated specifications.
• Ensure TMF documentation is complete, accurate, appropriately organized, and readily accessible.
• Create and maintain file structures and indexing systems to support efficient document management and retrieval.
• Review documentation for completeness and consistency while helping ensure alignment with applicable protocols and regulatory or local requirements.
• Communicate with client sponsors, project managers, clinical monitors, study sites, and other study contacts to resolve documentation issues and support compliance.
• Track and follow up on missing, incomplete, or inconsistent documentation as needed.
• Manage multiple documentation priorities while meeting established timelines and quality expectations.
• Collaborate with cross-functional clinical research teams to support effective study documentation and TMF management.
• Apply established document management practices and contribute to maintaining high standards of data and document integrity.
• Support broader clinical research and documentation activities as required.

Requirements

• Bachelor's degree in a relevant field such as science, nursing, biomedical sciences, or another related discipline.
• At least 1 year of professional document management experience.
• Experience in clinical research and/or Trial Master File management is preferred.
• Strong organizational skills with exceptional attention to detail and accuracy.
• Excellent written and verbal communication skills, with the ability to interact professionally with sponsors, project teams, monitors, sites, and other stakeholders.
• Strong interpersonal and collaboration skills, with the ability to work effectively as part of a distributed team.
• Ability to manage multiple priorities, organize competing deadlines, and maintain high-quality work in a fast-paced environment.
• Proficiency with Microsoft Office applications, particularly Word, Excel, and PowerPoint.
• Ability to work independently while maintaining clear communication and reliable follow-through.
• A professional approach grounded in integrity, trust, teamwork, and respect.

Benefits

• Compensation: $25$28 per hour.
• Remote work: Fully remote, home-based position available to candidates in US.
• Career development: Opportunity to build experience in clinical research, Trial Master File management, and regulated documentation environments.
• Collaborative environment: Work with multidisciplinary teams and a broad range of clinical research stakeholders.
• Meaningful impact: Contribute to clinical research programs that support the development and delivery of new medicines.
• Inclusive workplace: Equal opportunity employment with a commitment to a respectful and collaborative working environment.