Central Monitoring Specialist

3 days ago

Meerut, Uttar Pradesh, India beBeeClinical Full time ₹ 1,00,00,000 - ₹ 1,50,00,000
Key Role: Central Monitoring Expert

The central monitoring expert plays a pivotal role in driving data integrity, patient safety, and operational excellence across clinical development programs through advanced centralized monitoring and risk-based quality management (RBQM).

Responsibilities:
  • Develop RBQM Plans: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's needs.
  • Conduct Study Risk Assessments: Identify potential issues and develop mitigation strategies in consultation with functional team leads and PM.
  • Design and Oversee Centralized Statistical Monitoring Frameworks: Interpret complex data patterns, lead root cause analyses, and drive data-driven decision-making to enhance study quality and compliance.
  • Lead Facilitation of RBQM Meetings: Review and discuss study data, findings, action plans, and coordination of data cleaning activities to support study deliverables.
  • Ensure Data Quality Assurance and Oversight: Proactively monitor and intervene to maintain the highest standards of data quality and integrity.
  • 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.
  • Oversee Operational Study Metrics and Proactively Communicate Issues to Study Team Members to Drive Towards Resolution and Proactive Remediation.
  • Mentor Junior Colleagues: Share Best Practices, Lessons Learned, etc. to Improve Team Performance.
Qualifications and Skills:
  • Bachelor's Degree in a Relevant Field or Equivalent Combination of Education, Training, and Experience.
  • Minimum 8 Years Experience in Clinical Monitoring, Clinical Trial Management, or Equivalent.
  • Working Knowledge of ICH GCP Guidelines and the Clinical Development Process.
  • Statistical Analysis and Data Monitoring.
  • Risk Assessment and Mitigation.
  • Report Writing and Presentation.
  • Collaboration and Teamwork.

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