Data Integrity Specialist

Job Title : Central Monitoring Specialist

The central monitoring specialist plays a pivotal role in ensuring the integrity and accuracy of clinical trial data through proactive risk management, statistical data review, and centralized monitoring activities.

This position involves leading the development of quality management plans, conducting thorough study risk assessments, identifying key risk indicators, performing ongoing statistical data monitoring, remote data review, and facilitating regular meetings to discuss risk-based quality management.

The central monitoring specialist works independently and manages report review and issue escalation for complex studies or portfolios of work.

Further, the specialist may mentor junior colleagues, and support the development of processes, procedures, and documentation to ensure a high-performing team.

Key Responsibilities :

• Study Risk Assessment : Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
• Centralized Statistical Monitoring : Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
• Quality Management Meetings : Support regular meetings by reviewing study data, documenting findings, action plans, 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 and data cleaning for studies.
• Reporting : Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
• Operational Insights : Oversee operational study metrics, including data entry trends, SDV backlog, site health trending, and proactively communicate issues to study team members.

Qualifications

Preferred Qualifications

Skills Required