Centralized Monitoring Assistant

Roles & Responsibilities
• Oversee clinical deliverables from study start-up to close-out
• Support centralized monitors in identifying risks and resolving issues
• Review Site Visit Reports (SVRs) for quality, accuracy, and compliance
• Assist in development of monitoring strategies and risk mitigation plans
• Track study metrics, trends, and key performance indicators
• Monitor site performance and manage operational triggers
• Ensure adherence to Central Monitoring Plans (CMPs)
• Support unblinded monitoring activities and investigational product (IP) management when applicable
• Maintain accurate documentation and ensure audit readiness
• Contribute to training initiatives and continuous process improvement
• Assist with finance-related study data and investigator payments

Qualification
• Bachelor’s degree in Life Sciences / Medical / Scientific discipline
• OR Medical degree with relevant clinical research experience

Experience
• 1–5 years of experience as CRC, CTA, or in centralized monitoring

Skills
• Strong understanding of ICH-GCP, regulatory requirements, and clinical trial protocols
• Good knowledge of clinical data management and monitoring processes
• Centralized Monitoring experience
• Risk-Based Monitoring (RBM) knowledge
• Experience with clinical trial systems and analytics tools
• Issue management and trend analysis skills
• Strong communication, coordination, and organizational abilities

About the Organization
IQVIA India – A global leader in clinical research, analytics, and technology solutions, offering professionals the opportunity to work on global clinical trials in a hybrid work environment while building strong expertise in centralized and risk-based monitoring.