Celerion

Trial Master Files Representative

Celerion  •  United States (Remote)  •  2 days ago
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Job Description

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.
Celerion

About Celerion

Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines.

With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings.

Our operations are strategically located in:

Lincoln, Nebraska (Corporate Headquarters)

Philadelphia, Pennsylvania

Phoenix, Arizona

Belfast, Northern Ireland,UK

Zurich, Switzerland

Vienna, Austria

Richmond, Virginia

Montreal, Quebec, Canada

For more information, visit: www.celerion.com

Industry
Chemicals & Materials
Company Size
1,001-5,000 employees
Headquarters
Lincoln, NE
Year Founded
2010
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