FSP Central Monitoring Operations Manager
Core
Identifies and characterizes issues and trends in operational and patient clinical trial data using analytical or statistical tools to communicate risks and support risk mitigation strategies.
Role type
Senior Central Monitoring Operations Manager
Builds
Site monitoring strategy, oversight, and risk mitigation for clinical trials
Domain
Clinical Trials / Life Sciences
Required skills
Site monitoring strategy, risk assessment, trend analysis, signal detection, protocol compliance, ICH-GCP knowledge, patient safety oversight, data integrity management, cross-functional coordination, team leadership
Preferred skills
Scientific and therapeutic knowledge, operational expertise across trial planning and execution, complex matrix structure navigation, strategic alignment
Technologies
Analytical or statistical tools
Responsibilities
Author risk assessments and monitoring plans, ensure sponsor oversight and trend analysis, lead implementation of monitoring approaches, oversee planning and execution of site monitoring activities, ensure compliance with regulatory requirements, safeguard patient safety and data integrity
Seniority
Senior, hands-on IC with leadership responsibilities
