Monitoring Operations Specialist

1 week ago

Tiruchi, Tamil Nadu, India beBeeClinical Full time ₹ 45,00,000 - ₹ 75,00,000
Job Summary

The Central Monitor II plays a pivotal role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.

  • 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.
Required Skills and Qualifications
  • 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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