Found Description
Location: India/UK/Canada
Position Summary
The Centralized Monitoring Lead is responsible for leading Risk-Based Quality Management (RBQM) and centralized monitoring activities across global medical device clinical investigations. This role partners closely with Clinical Operations, Data Management, Biostatistics, Medical Affairs, Quality Assurance, Regulatory Affairs, and Clinical Data Review teams to proactively identify risks, ensure data quality, protect subject safety, and maintain regulatory compliance throughout the study lifecycle
The individual will lead centralized monitoring activities in accordance with ISO 14155, ICH-GCP, FDA, MDR, and applicable global regulatory requirements while driving data-driven decision-making and continuous quality improvement
Key Responsibilities (but not limited to)
Risk-Based Quality Management (RBQM)
- Lead the imple...