
Senior Clinical Operations Specialist
2 days ago
The Central Monitor II plays a pivotal 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 Risk-Based Quality Management (RBQM) plans and conducts study risk assessments to identify potential issues and develop mitigation strategies.
- Performs centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
- Supports monthly RBQM Meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities.
- Ensures the highest standards of data quality and integrity through proactive monitoring and timely interventions.
- Collaborates with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.
- Prepares detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
- Bachelor's Degree: Relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience.
- Experience: Minimum 2 years in clinical monitoring, clinical trial management or equivalent.
- Working Knowledge: ICH GCP guidelines and the clinical development process.
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