Prepare, maintain, and ensure completeness of Trial Master Files (TMF) for internal and external studies. Create file structures, index contents, and communicate with sponsors, project managers, monitors, and sites to ensure protocol and regulatory compliance.
TMF Representative
Join a team that's going places! Every member of Celerion is involved in making a distinctive contribution to the health and well-being of people around the world. That's the sense of purpose shared by our employees. We are a performance-driven drug research company, operating in robust and growing markets. We have an exciting future and offer a competitive salary in a strong developmental environment.
Celerion, a leader in the clinical research industry, currently has an opportunity for a TMF Representative to join our team. This is a remote, home-based position within the UK. Applicants must have full and permanent right to work in the UK, Celerion does not currently offer Sponsorships.
In this position, 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 be responsible for maintenance of the Trial Master File, creating a file structure and indexing contents. You will also communicate with client Sponsors, Project Managers, monitors, sites and other study contacts to ensure compliance to protocol, and regulatory/local requirements.
Requirements
- Bachelor's degree in related field such as science or other biomedical discipline
- Experience in clinical research and/or Trial Master Files preferred
- Minimum 1 year document management experience.
- Excellent interpersonal and oral/ written communication skills.
- Highly organized and collaborative.
- Proficient computer skills, i.e., MS Word, Excel, PowerPoint.
- Ability to manage multiple priorities
Celerion Values: Integrity Trust Teamwork Respect
Are you ready to join our team?
Celerion is an Equal Opportunity Employer.
Celerion Belfast, Northern Ireland Office
22-24 Lisburn Road, Belfast, United Kingdom, BT9 6AD
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