Data Integrity Specialist

3 days ago

Mount Abu, Rajasthan, India beBeeClinical Full time ₹ 15,00,000 - ₹ 18,00,000

Ensuring Data Integrity and Excellence

Job Role:
  • We are seeking a skilled Central Monitor II to play a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.
Key Responsibilities:
  1. Develop and Implement Quality Management Plans: Design and implement Risk-Based Quality Management (RBQM) plans to ensure high-quality data.
  2. Study Risk Assessments and Mitigation: Conduct study risk assessments and identify potential issues, developing mitigation strategies in consultation with functional team leads and project managers.
  3. Statistical Monitoring and Analysis: Perform centralized statistical monitoring and data analysis to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
  4. Monthly RBQM Meetings Support: Support monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables.
  5. Proactive Monitoring and Intervention: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
  6. Collaboration with Departments: Collaborate closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.
  7. Report and Presentation Preparation: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
Requirements:
  • A bachelor's degree in a relevant field or 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.
Preferred Qualifications:
  • Central Monitor experience within CROs.

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