Principal Central Monitor / Risk Manager

Overview

The Principal Central Monitor (Risk Manager) leads enterprise-wide RBQM strategy for clinical development programs, focusing on centralized monitoring, risk assessment, and data integrity.

What you'll do

• Design and implement RBQM plans tailored to each study.
• Conduct study risk assessments and develop mitigation strategies.
• Design and oversee centralized statistical monitoring frameworks.
• Facilitate monthly RBQM meetings and review KRIs, data trends, and action plans.
• Ensure data quality and integrity through proactive monitoring and interventions.
• Prepare reports and presentations on monitoring activities, findings, and recommendations.
• Oversee operational study metrics and communicate issues for resolution.

What you'll need

• 10+ years experience in clinical monitoring, clinical trial management, or equivalent.
• Strong written and oral communication skills, including scientific vocabulary.
• Minimum Bachelor’s degree in a relevant field (life sciences, statistics, data management, clinical operations) or equivalent combination.
• Working knowledge of ICH GCP guidelines and the clinical development process.
• Strong understanding of RBQM principles and methodologies.
• Proficiency in statistical analysis and data monitoring tools.

Details

• Location: Bangalore, Karnataka, India.