Clinical Data Coordinator

• Ensure completeness, quality, and integrity of clinical data in the database
• Perform or oversee data management document development
• Perform database UAT and QC activities
• Organize and perform data review and query management activities
• Review local laboratory normal ranges and contact the study team regarding issues
• Perform SAE reconciliation and external data reconciliation
• Generate data status reports
• Perform data quality control
• Archive data management documentation
• Contribute to SOP, process, and system enhancements
• Create and maintain eCRF specifications and Data Validation Plans with guidance
• Create and maintain data management documentation, including Data Management Plans, eCRF completion guidelines, and SAE reconciliation plans