Senior Data Integrity Specialist
7 days ago
Key Responsibilities:
- Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
- Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks.
- Support monthly Risk-Based Quality Management (RBQM) meetings by reviewing study data, documenting findings, and coordinating data cleaning activities.
- Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
- Collaborate with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management.
- Prepare detailed reports and presentations on monitoring activities, findings, and recommendations.
- Bachelor's Degree in life sciences, statistics, data management, or clinical operations.
- 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
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