Clinical Trial Data Analyst

2 days ago

Erode, Tamil Nadu, India beBeeQuality Full time ₹ 12,00,000 - ₹ 17,00,000
Senior Quality Assurance Specialist

This is a senior quality assurance specialist position that plays a pivotal role in ensuring the integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.

The ideal candidate will be responsible for leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study Key Risk Indicators (KRIs), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings.

This position involves mentoring junior colleagues, supporting the development of processes, procedures, and other documentation to ensure a high-functioning team, and collaborating with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.

  • 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 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.

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