Analyst

• Analyze scientific and operational data to support the Data Surveillance process
• Review project-specific Quality Tolerance Limits
• Assist in developing Data Surveillance Plans (DSPs) and conduct defined project reviews
• Attend internal and external Data Surveillance meetings, presenting relevant findings to the project team
• Support cross-functional study team with expertise of Data Surveillance Process
• Support the development of a robust Data Surveillance Plan, including Key Risk Indicators, Quality Tolerance Limits
• Configure and Maintain Data Surveillance technologies (e.g., Clue Points Central Monitoring Platform)
• Review relevant data via scoped technologies, identifying trends, outliers, emerging risks, and systemic issues
• Document findings from Data Surveillance review and provide feedback
• Work with Technology teams to identify potential solutions
• Perform presentations explaining identified findings
• Actively participate in external or internal meetings and audits & regulatory inspections as required
• Communicate/promptly escalate issues that require immediate action
• Maintain a working knowledge of ICH-GCP Guidelines and ensure compliance
• Collaborate with Data Surveillance Team Members to correlate findings
• Support Project Leads with review meeting driving reviews and decisions
• Engage DS Team to compile signals/actions into client ready list
• Support documentation of actions in Clue Points Issue Management system
• Complete, share, and file Central Monitoring Report
• Support Data Surveillance close out activities

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