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Clinical Data Coordinator

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Working knowledge of Good Clinical Practices (GCPs), of Good Laboratory Practices (GLPs), clinical development, and of medical terminology preferred. Participate in all laboratory reference data management activities including generation of new laboratory source codes, laboratory parameter codes, and names, entry of reference ranges, and resolution of reference range discrepancies. Maintain global laboratory reference data including reference ranges, lab source codes, conversion files, and unit files for the laboratory data management system. Load and transfer electronic data consisting of central laboratory data and medical device data in the clinical trial database. Generate external data file format specifications and ensure that business partners comply with approved specifications. Coordinate ongoing data transmissions and provide resolution to technical issues. Experience with at least one relational database management system (SAS, Oracle, Clintrial, Oracle Clinical, Recorder, EDC), data processing, quality control and audit procedures; knowledge of the drug discovery Phase I - III process, ICH, GCP, and FDA regulations pertaining to data quality and clinical trial conduct.


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