Clinical Data Manager
ProKatchers LLC
Specific Skills : Clinical Data, CDM, clinical study, database, data-handling
Job Category : Clinical
Industry : Pharmaceutical, Medical Device, biotech, healthcare
Job Description :
- Minimum 5 years’ experience working for a Medical Device, Pharmaceutical or Biopharmaceutical Company.
- Minimum 2 years’ experience using a clinical data management system performing clinical study database setup including edit check programming.
- Prior experience in study specific database configuration utilizing Oracle Clinical, Oracle Clinical Inform, or Oracle Life Sciences Cloud or other data management systems.
- Experience in adherence to FDA 21 CFR Part 11 and Guidance for Good Clinical Practices (GCP) data-handling procedures and guidelines.
- Lead and/or participate in set-up of clinical study databases in a clinical data management system including programming of edit checks.
Reference: WJ-5408_11452424