Contract Clinical Data Management Quality and Compliance Consultant | Remote (West Coast Preferred)
||Clinical Data Management Quality and Compliance Consultant
|| Remote (West Coast Preferred)
||Clinical Data Management
||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
Bachelor degree in biological science or a related discipline in the science/healthcare field or equivalent education.
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.
- 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.