Clinical Data Integrity Specialist

24 hours ago

Aurangabad, Maharashtra, India beBeeRiskAssessment Full time ₹ 1,00,00,000 - ₹ 1,50,00,000
Job Opportunity

This role is for a skilled professional to lead centralized monitoring activities, statistical data review, and proactive risk management. The Central Monitor II plays a pivotal part in ensuring the quality and integrity of clinical trial data.

The position involves overseeing the development of Risk-Based Quality Management (RBQM) plans, conducting thorough study risk assessments, identifying key risk indicators, performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings.

The Central Monitor II works independently, managing report review and issue escalation for complex studies and/or portfolios of work. They may also mentor junior colleagues, support process development, and ensure a high-functioning team.

Key Responsibilities:
  • Study Risk Assessment: Conduct detailed 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 and 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.
Requirements

A 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.

Additional Skills:
  • Excellent communication and organizational skills.
  • Strong analytical and problem-solving abilities.
  • Proficiency in statistical analysis and data monitoring tools.
  • Detail-oriented with strong teamwork and time management skills.
Preferred Qualifications:
  • CRO experience as a Central Monitor.
Essential Skills:
  • Statistical analysis and data monitoring.
  • Risk assessment and mitigation.
  • Report writing and presentation.

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