Openings >> Principal Clinical Data Manager (EDC)
Principal Clinical Data Manager (EDC)
Summary
Title:Principal Clinical Data Manager (EDC)
ID:2804
Location:Remote - United States
Department:Data Management and Biometrics
Job Status:Full-time, Benefited
Description
Celerion, a global leader in clinical research, seeks an experienced EDC data manager to join our team! This is a fulltime position, which works remotely from home with some travel.

The Principle Clinical Data Manager provides comprehensive data management expertise and manages end-to-end delivery of data management services.
  • Responsible for the integrity of the data entered into a Celerion eCRF and database, Sponsor provided EDC database and/or Sponsor provided Paper CRF.
  • Ensures database is complete, accurate and consistent and meets quality standards required by Sponsors and regulatory bodies.
  • Represents data management as a subject matter expert on multidisciplinary teams involved in setting up, running and reporting clinical trials.
  • Responsible for Sponsor contact, project communication and timeline management for all data management functions.
  • Manages, organizes and processes clinical data using a range of computer applications and database systems to facilitate collection and cleaning of subject data.
  • Serves as a team leader/mentor and provides day-to-day guidance and training to other members of the Data Management team.

Knowledge/Skills/Education/Licenses*:

  • Bachelor degree in Business, Science or related field or a combination of education and relevant internal Celerion experience in lieu required
  • Minimum of 5 years industry experience required
  • Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred
  • Knowledge of SAS preferred
  • Ability to manage multiple projects/priorities required
  • High attention to detail required
  • Excellent oral and written communication skills required
  • Excellent organizational skills required
  • Proficiency in MS office applications required
EEO/AA M/F / Vet / Disability
 
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