Central Monitoring Specialist

18 hours ago

Bengaluru, Karnataka, India beBeeRisk Full time ₹ 20,00,000 - ₹ 25,00,000
Senior Central Monitor Job Description

The Senior 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 position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study Key Risk Indicators (KRIs), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings.

This is an opportunity to work closely with cross-functional teams, including clinical operations, data management, biostatistics, and other departments, to support proactive oversight and management and data cleaning for studies. The ideal candidate will have excellent organizational and time management skills, strong written and spoken English, and a demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk.

Responsibilities:

  • Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's specific needs.
  • Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
  • Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks.
  • Risk-Based Quality Management Meetings: Lead facilitation of monthly RBQM meetings by supporting review of study data, documenting findings, action plans, and coordination of data cleaning activities.
  • 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.
  • Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending, and proactively communicate issues to study team members.

Requirements:

  • Bachelor's Degree in a relevant field or equivalent combination of education, training, and experience.
  • Minimum 5 years experience in clinical monitoring, clinical trial management or equivalent.
  • Working knowledge of ICH GCP guidelines and the clinical development process.

Preferred Skills:

  • CRO experience as a Central Monitor.
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