Trial Master File Representative

Summary

Join Celerion, a leading clinical research company, as a remote TMF Representative based in the UK. This role focuses on preparing and maintaining Trial Master Files (TMF) for internal and external studies, ensuring compliance with sponsor specifications and regulatory requirements. You will be responsible for file structure, indexing, and communication with clients and study contacts. The position requires a Bachelor's degree in a related field, experience in clinical research or TMFs, and excellent communication and organizational skills. Celerion offers a competitive salary and a strong developmental environment.

Requirements

• Hold a Bachelor's degree in a related field such as science or other biomedical discipline
• Have minimum 1 year document management experience
• Possess excellent interpersonal and oral/written communication skills
• Be highly organized and collaborative
• Have proficient computer skills, i.e., MS Word, Excel, PowerPoint
• Be able to manage multiple priorities

Responsibilities

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

Preferred Qualifications

Have experience in clinical research and/or Trial Master Files