Medical Reviewer

• Ensure data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews and publications
• Review participant level data across a study in adherence with CRF Completion guidelines (CCGs) and the Data Review Plan (DRP)
• Conduct point-to-point data checks (e.g. verifying the presence of a lab test that satisfies study inclusion criteria) and interpretive analysis (e.g. reviewing to identify inconsistencies in the participant’s data).
• Generate queries on discrepant data and follow to resolution including escalation of issues that cannot be resolved through the query process
• Create and use data review best practices and associated data review tools to identify trends and any safety signals
• May identify protocol deviations during routine clinical review and escalation as appropriate
• Follow relevant SOPs and regulations, have an excellent understanding of and comply with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures
• May liaise with data management, clinical and site management along with other members of the study team Attend Clinical Meetings and Study Meetings, as necessary

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Clinical Data Reviewer, Internal Medicine