Data Quality Specialist

1 week ago

Cochin, Kerala, India beBeeData Full time ₹ 15,00,000 - ₹ 20,00,000

Central Data Manager Role

The Central Data Manager plays a pivotal part in upholding the quality and integrity of clinical trial data via centralized monitoring activities, statistical data review, and proactive risk management.

  • Lead the creation of Risk-Based Quality Management (RBQM) plans and execute study risk assessments.
  • Identify study Key Risk Indicators (KRIs) and conduct ongoing centralized statistical monitoring and remote centralized data review.
  • Facilitate regular RBQM meetings and manage report review and issue escalation for complex studies and/or portfolios of work.
  • Mentor junior colleagues and support the development of processes, procedures, and 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.
  • Centralized Statistical Monitoring: Perform centralized statistical monitoring and data analysis on study data to detect anomalies, trends, and potential risks.
  • Risk-Based Quality Management Meetings: Support regular RBQM meetings by reviewing study data, documenting findings, and coordinating data cleaning activities.
  • 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.
  • 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, and site health trending.

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