Senior Clinical Data Specialist

Job Overview

The Central Monitor II is responsible for ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.

Main Responsibilities

• Risk Assessment and Mitigation : Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies in consultation with functional team leads and Project Managers.
• Data Analysis and Review : Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks ensuring data accuracy and compliance.
• Support RBQM Meetings : Assist in monthly Risk-Based Quality Management meetings by reviewing study data, documenting findings, action plans and coordinating data cleaning activities to support study deliverables.
• Data Integrity and Quality : Ensure highest standards of data quality and integrity through proactive monitoring and timely interventions.
• Collaboration and Communication : Collaborate with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.
• Reporting and Presentations : Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.

Requirements