Principal Central Monitor / Risk Manager

Overview

The Principal Central Monitor (Risk Manager) leads enterprise-wide RBQM strategy and advanced centralized monitoring to support data integrity, patient safety, and operational excellence across clinical development programs.

What you'll do

• Collaborate to design and implement comprehensive RBQM plans tailored to each study.
• Conduct study risk assessments and develop mitigation strategies with functional team leads.
• Design and oversee centralized statistical monitoring frameworks and interpret complex data to drive decisions.
• Lead monthly RBQM meetings to review data, findings, action plans, and data cleaning coordination.
• Ensure data quality and integrity through proactive monitoring and timely interventions.
• Prepare reports and presentations summarizing monitoring activities, findings, and recommendations.

What you'll need

• Minimum 10+ years experience in clinical monitoring, clinical trial management, or equivalent.
• Bachelor’s degree in a relevant field (life sciences, statistics, data management, clinical operations) or equivalent training/experience.
• Working knowledge of ICH GCP guidelines and the clinical development process.
• Highly effective oral and written communication skills, including strong English grammar and scientific vocabulary.
• Strong organizational and time management skills.
• Ability to learn how to extract pertinent information from protocols and clinical/monitoring systems and assess risk.
• Proficiency in statistical analysis and data monitoring tools.

Details

• Location: Bangalore, Karnataka, India.