Trial Master File Representative (Remote - UK)

This is a remote, home-based position within the UK. Applicants must have full and permanent right to work in the UK.

About the role

You will be responsible for the preparation and the completeness of the Trial Master Files (TMF) for internal and external studies where Celerion has been contracted for the TMF services to meet Sponsor negotiated specifications. You will maintain the Trial Master File, create file structures, and index contents. You will also communicate with client Sponsors, Project Managers, monitors, sites, and other study contacts to ensure compliance with protocol and regulatory/local requirements.

Responsibilities

• Prepare and ensure completeness of Trial Master Files (TMF) for internal and external studies.
• Maintain the Trial Master File, including creating file structures and indexing contents.
• Communicate with client Sponsors, Project Managers, monitors, sites, and other study contacts to ensure compliance with protocol and regulatory/local requirements.

Requirements

• Bachelor's degree in a related field such as science or other biomedical discipline.
• Experience in clinical research and/or Trial Master Files preferred.
• Minimum 1 year of document management experience.
• Excellent interpersonal and oral/written communication skills.
• Highly organized and collaborative.
• Proficient computer skills, including MS Word, Excel, and PowerPoint.
• Ability to manage multiple priorities.

Values

• Integrity
• Trust
• Teamwork
• Respect