Clinical Data Specialist
2 weeks 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:- Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and project managers.
- Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis 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: Ensure 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.
- Operational Insights: 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 & proactive remediation.
- Education: Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience.
- Experience: Minimum 2 years experience in clinical monitoring, clinical trial management or equivalent.
- Knowledge: Working knowledge of ICH GCP guidelines and the clinical development process.
This is an exciting opportunity to join our organization as a Central Monitor II. If you are a detail-oriented individual with strong analytical and problem-solving skills, we encourage you to apply.
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