Central Data Integrity Specialist

3 hours ago

Nashik, Maharashtra, India beBeeClinical Full time ₹ 80,00,000 - ₹ 1,20,00,000

Job Title: Central Data Integrity Specialist

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This role plays a crucial part in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.

Main Responsibilities:
  • Develop Risk-Based Quality Management (RBQM) plans and conduct study risk assessments to identify potential issues and develop mitigation strategies.
  • Perform centralized statistical monitoring and data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
  • Support monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables.
  • Evaluate and ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
  • Collaborate with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.
  • Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
Qualifications and Requirements:
  • Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience.
  • Minimum 2 years experience in clinical monitoring, clinical trial management, or equivalent.
  • Working knowledge of ICH GCP guidelines and the clinical development process.

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