Clinical Trials Data Integrity Specialist

1 day ago

Salem, Tamil Nadu, India beBeeData Full time ₹ 10,40,000 - ₹ 16,40,000
Job Title:

Quality Assurance Specialist

\\About the Role:\

The Quality Assurance Specialist will play a key role in ensuring the integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.

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

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Key responsibilities include but are not limited to:

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  • 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 and proactive remediation.\
  • Mentor junior colleagues and support the development of processes, procedures, and other documentation to ensure a high-functioning team.\
  • Develop and implement effective monitoring plans and provide training to new staff members as needed.
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Qualifications:\

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