Clinical Data Manager

Trident Consulting
Aliso Viejo, CA
Category Healthcare
Job Description
Trident Consulting is seeking a Clinical Data Manager II to support clinical study data management activities for one of our industry leading clients. The ideal candidate will have hands-on experience in clinical data management, EDC systems, data review, and regulatory compliance within pharmaceutical, biotechnology, medical device, or CRO environments.

Requirements

  • 2-5 years of Clinical Data Management experience
  • Experience within Pharmaceutical, Biotechnology, Medical Device, or CRO environments
  • Strong knowledge of FDA, ICH-GCP, and clinical data management regulations and guidelines
  • Hands-on experience with Electronic Data Capture (EDC) systems such as Medidata RAVE, Oracle Inform, iMedNet, and similar EDC platforms
  • Experience with clinical database design concepts and data review tools
  • Knowledge of CDISC standards including CDASH and SDTM
  • Experience writing and maintaining Data Management documentation
  • Experience with data review, query management, and reconciliation processes
  • Strong project coordination, organizational, and analytical skills
  • Excellent verbal and written communication skills
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