Monitoring Specialist

2 days ago

Alwar, Rajasthan, India beBeeClinical Full time ₹ 18,46,000 - ₹ 24,58,000
Job Opportunity: Central Monitoring Specialist

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

  • This involves developing risk-based quality management plans, conducting study risk assessments, and identifying study key risk indicators in collaboration with functional leads.
  • Performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly risk-based quality management meetings are essential responsibilities.
  • Mentoring junior colleagues and supporting the development of processes, procedures, and other documentation to ensure a high-functioning team is crucial.
Key Responsibilities:
  1. 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.
  2. Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
  3. RBQM Meetings: Support monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables.
  4. Data Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
  5. Cross-Functional Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.
  6. 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 of experience in clinical monitoring, clinical trial management, or equivalent.
  • Working knowledge of ICH GCP guidelines and the clinical development process.

Essential skills include statistical analysis and data monitoring, risk assessment and mitigation, report writing and presentation, and collaboration and teamwork.

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