Chief Clinical Operations Specialist

Central Monitor II

The Central Monitor II plays a pivotal role in ensuring the integrity and quality of clinical trial data through centralized monitoring activities, statistical analysis, and proactive risk management.

This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting thorough study risk assessments , identifying key performance indicators, performing ongoing centralized statistical monitoring , remote centralized data review, and facilitating regular RBQM meetings .

Key responsibilities include :

• Study Risk Assessment : Conduct comprehensive risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
• Centralized Statistical Monitoring : Perform centralized statistical analysis and monitoring on study data to detect anomalies, trends, and potential risks.
• RBQM Meetings : Support regular RBQM meetings by reviewing study data, documenting findings, and coordinating data cleaning activities.
• Data Quality Assurance : Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
• Collaboration : Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management.
• Reporting : Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.

Requirements :