Senior Clinical Data Manager

1 day ago

Bharatpur, Rajasthan, India beBeeData Full time ₹ 1,20,00,000 - ₹ 1,50,00,000
Job Summary

The Central Monitor II is a pivotal role in ensuring the integrity and quality of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.

This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying key risk indicators (KRIs), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings.

The Central Monitor II works independently and manages report review and issue escalation for more complex studies and/or portfolios of work. Further, this role may mentor junior colleagues, and may support the development of processes, procedures, and other documentation to ensure a high-functioning team.

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.
  • RBQM Meetings: Support monthly RBQM meetings by supporting review of study data, documenting findings, action plans, and coordination of 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.

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