
Clinical Data Quality Specialist
7 days ago
**Job Title:** Clinical Data Quality Specialist
The Central Monitor II plays a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.
This position involves 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 Clinical Data Quality Specialist works independently and manages report review and issue escalation for more complex studies and/or portfolios of work. Additionally, they may mentor junior colleagues and support the development of processes, procedures, and other documentation to ensure a high-functioning team.
**Key Responsibilities:- Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and program managers.
- Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
- Support monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables.
- Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
- Collaborate closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.
- Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
- 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.
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