Note: The job is a remote job and is open to candidates in USA. Celerion is committed to swift, exceptional clinical research through translational medicine. In this role, you will be involved in the preparation and maintenance of Trial Master Files for studies, ensuring compliance with protocol and regulatory requirements.
Responsibilities
- Involved in the preparation and the completeness of the Trial Master Files (TMF) for internal and external studies
- Responsible for maintenance of the TMF, 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
Skills
- Bachelor's degree in related field such as science, nursing, or other biomedical discipline
- 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
- Experience in clinical research and/or Trial Master Files preferred
Company Overview
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. It was founded in 2010, and is headquartered in Lincoln, Nebraska, USA, with a workforce of 1001-5000 employees. Its website is https://celerion.com/.