Trial Master Files Representative

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.