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CelerionCE

Trial Master Files Representative

Celerion is a leading Clinical Research Organization focused on accelerating early phase drug development through innovative strategies and comprehensive research services.

Celerion

Employee count: 1001-5000

United States only

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Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
Celerion, a leader in the clinical research industry, currently has an opportunity for a Full-Time Trial Master Files Representative to join our team. This is a remote, home-based position and may be filled from any US geography.
In this position, you will be be involved in 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 TMF, 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, nursing, 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
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

About the job

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Job type

Full Time

Experience level

Entry-level

Location requirements

Hiring timezones

United States +/- 0 hours

About Celerion

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Celerion is a prominent Clinical Research Organization (CRO) that specializes in early phase drug development services, working diligently to support pharmaceutical companies in expediting their products to market. Established in 2010, Celerion has since earned its reputation as a leader in the industry, utilizing over 40 years of collective experience in clinical research and applied translational medicine. Our key focus is to provide clients with rapid, reliable data that allows for informed go/no-go decisions during the drug development process.

In-depth knowledge, innovative methodology, and a global network of expert professionals form the backbone of Celerion’s operations. We conduct first-in-human trials, proof-of-concept studies, and provide comprehensive bioanalytical support, which helps ensure that all projects are managed efficiently across various therapeutic areas. The company boasts an extensive range of clinical facilities worldwide and is committed to maintaining the highest ethical standards in research. By integrating the latest technologies into our clinical trials, we enhance the quality and speed of data delivery to our clients, ensuring they can bring life-changing therapies to patients in need effectively. Celerion’s mission is not just about conducting studies; it is about advancing health innovation through collaboration and scientific excellence, thereby making a meaningful difference in the lives of individuals around the globe.

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Celerion

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