Medical Officer

• Collaborate closely with the Study Medical Reviewer
• Manage and review the medical consistency of reported clinical data
• Ensure medical data in databases are accurate, reliable, and analyzable
• Review study protocols, especially safety management, coding needs, inclusion and selection criteria, study design, pathology, and mechanism of action of the IMP
• Review database specifications and perform user acceptance testing on eCRFs and database validation tools
• Participate in identifying and implementing Important Protocol Deviation detection methods, including specifications and UAT
• Perform medical coding of adverse events, medical and surgical history, specific events, treatments, and treatment indications
• Review medical data entered by investigators using available tools and processes
• Create manual queries for clarification, confirmation, or correction when needed
• Identify non-serious adverse events according to the study strategy
• Handle data extraction to support important study milestones

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