Data Quality Specialist

Job Description

The role of Central Monitor II is a vital position within our organization, responsible for ensuring the integrity and quality of clinical trial data through centralized monitoring activities. This includes statistical data review and proactive risk management.

This position requires leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study Key Risk Indicators (KRIs), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings.

The Central Monitor II works independently and manages report review and issue escalation for more complex studies and / or portfolios of work.

• Study Risk Assessment : Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies in consultation with functional team leads and Project Managers.
• Centralized Statistical Monitoring : Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
• RBQM Meetings : Support monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables.
• 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 to drive towards resolution and proactive remediation.

Required Skills and Qualifications

Benefits

We offer a competitive salary and benefits package to successful candidates.

Others

A strong understanding of RBQM principles and methodologies is essential for this role. Proficiency in statistical analysis and data monitoring tools is also required.