
Central Data Quality Specialist
1 day ago
Job Opportunity:
Central Data Quality SpecialistWe are seeking a Central Data Quality Specialist to play a critical role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.
Key Responsibilities:
- Develops and implements Risk-Based Quality Management (RBQM) plans to ensure high-quality data.
- Conducts thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
Data Review and Analysis:
- Performs centralized statistical monitoring and data analysis on study data to detect anomalies, trends, and potential risks.
- Ensures data accuracy and compliance with ICH GCP guidelines and the clinical development process.
Collaboration and Communication:
- Works closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management.
- Prepares detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
Qualifications:
- Bachelor's Degree in a relevant field or equivalent combination of education, training, and experience.
- Minimum 2 years experience in clinical monitoring, clinical trial management, or equivalent.
Skills:
- Statistical analysis and data monitoring
- Risk assessment and mitigation
- Report writing and presentation
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