Clinical Data Management Quality and Compliance Consultant (Remote)

Contract Clinical Data Management Quality and Compliance Consultant | Remote (West Coast Preferred)

Job Title: Clinical Data Management Quality and Compliance Consultant
Location:  Remote (West Coast Preferred)
Job Category: Clinical Data Management
Travel Required:  N/A
Position Type: Contract – Remote

Role and Responsibilities

In this role, the consultant will prepare the data management team for audit readiness. This person will be responsible for the following:

  • Develop and approve data quality oversight plans
  • Performs document quality review in our TMF
  • Inspect the quality of data and data review as well as provides summary reports
  • Inspect the quality of our vendor SOPs and report any compliance gaps
  • Provide summary reports for our vendor SOPs
  • Track the transition of our FSP and in-house studies to our newly created SOPs

Education Requirements

Bachelor degree in biological science or a related discipline in the science/healthcare field or equivalent education.

Experience

Minimum 12+ years of experience in CDM in a CRO or pharmaceutical industry, or an equivalent combination of education and experience to successfully perform key responsibilities of the job.

Preferred Skills

  • Thorough knowledge of all technical elements of Data Management.
  • Understanding of ICH-GCP principles.
  • Thorough understanding of medical terminology and clinical research terminology.
  • Varied therapeutic area experience.
  • Demonstrated ability to provide coaching and training to new hires and less- experienced colleagues.
  • Communicates effectively through both written and verbal methods.
  • Manages time effectively to produce quality deliverables in the expected timeframe.

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