Title Clinical Data Manager
LocationRemote
Job Information

The Clinical Data Manager position must have experience leading and conducting data management activities from start up to close out.

Knowledge and Skills

  • Proficient in core data management activities (e.g., case report form design, data edit specifications and data validation, creation of data management plans, expert use of adverse events and concomitant medication coding dictionaries, attention to detail and data quality)
  • Knowledge of CDISC standards for CDASH and SDTM is a plus
  • Lead and coordinate User Acceptance Testing
  • Experienced managing third party vendors such as CROs, EDC vendors, and local/central laboratories on defined data standards, content specifications, and timelines for deliverables
  • Data preparation for reporting clinical study results for regulatory filings, publications, presentations
  • Conduct clinical data management activities using Electronic Data Capture (EDC) systems such as OmniComm’s Trial Master, Medrio, ClinCapture, Medidata Rave, and/or InForm

 

Work Experience

  1. Minimum education: BS in life sciences or related field
  2. Minimum experience: 6 years managing clinical trial data in a pharmaceutical, biotech, or CRO setting
  3. Exceptional communication (oral and written) and interpersonal/team skills

 

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