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Senior Trial Master Files Representative
3 months ago
**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.
- The Senior TMF Representative is responsible for the preparation and the completeness of the Trial Master Files (TMF) for internal and external studies where Celerion has been contracted for TMF services based upon Sponsor negotiated specifications._
**Essential Functions**
- Responsible for staff management in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees.
- Communicate directly with the Sponsors, Project Manager, monitors, sites and other study contacts to ensure timely receipt of the required TMF documents.
- Create and maintain the TMF file index and appropriate files according to the regulations and client-specific guidelines.
- Create and maintain an electronic TMF file structure as applicable for internal and external access and within the regulatory guidance documents requirements according to the client specific guidelines and study criteria.
JOB REQUIREMENTS
**Education and skills requirements**:
- Bachelor's degree in related field such as science, nursing, or other biomedical discipline preferred
- Experience in clinical research and/or Trial Master Files preferred
- Minimum 3 years TMF management experience
- Excellent interpersonal and oral/ written communication skills.
- Highly organized and collaborative
- Proficient computer skills, i.e., MS Word, Excel, PowerPoint. Veeva experience desirable.
- Ability to manage multiple priorities
An attractive salary and benefits package is available including pension, life assurance, income protection insurance and private medical insurance. Salary will be based on experience.
- Please note:_
This is a remote, home-office based position in the UK. While work hours are flexible, there are core hours within which you must be online and available for contact and meetings, etc. Prior experience successfully working remote is not a requirement, but is a plus.
**Celerion Values: Integrity Trust Teamwork Respect**
Are you ready to join our team?
- Celerion is an Equal Opportunity Employer_
LI-Remote
