
Clinical Data Quality Specialist
1 day ago
The role of a Clinical Data Quality Specialist plays a crucial part in ensuring the integrity and quality of clinical trial data through centralized monitoring activities, statistical analysis, and proactive risk management.
Key Responsibilities- Develop and lead Risk-Based Quality Management (RBQM) plans by conducting thorough study risk assessments, identifying Key Risk Indicators (KRIs), and performing ongoing centralized statistical monitoring.
- Conduct remote centralized data review, facilitate monthly RBQM meetings, and manage report review and issue escalation for complex studies and/or portfolios of work.
- Mentor junior colleagues to support the development of processes, procedures, and documentation, ensuring a high-functioning team.
- Study Risk Assessment: Conduct comprehensive risk assessments for clinical studies, identifying potential issues and developing mitigation strategies in collaboration with functional team leads and Project Managers.
- Centralized Statistical Monitoring: Perform centralized statistical analysis & data monitoring on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
- Risk-Based Quality Management 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: Maintain 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.
- Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience.
- Minimum 2 years' experience in clinical monitoring, clinical trial management, or equivalent.
- Working knowledge of ICH GCP guidelines and the clinical development process.
- Statistical analysis and data monitoring.
- Risk assessment and mitigation.
- Report writing and presentation.
- Collaboration and teamwork.
A dynamic work environment that supports career growth and professional development.
How to ApplyPlease submit your application to be considered for this exciting opportunity.
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