Risk and Central Monitoring Associate Manager
Core
Lead Risk-Based Quality Management (RBQM) and Central Monitoring strategies to ensure clinical trial quality and integrity.
Role type
Associate Manager, Clinical Research Quality & Monitoring
Builds
Centralized monitoring plans, risk dashboards, and data-driven mitigation strategies for clinical studies
Domain
Clinical Research / Medical Innovation
Deliverable
dashboards & analysis
Required skills
Risk-Based Quality Management (RBQM), Central Monitoring, Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), Clinical Data Analysis, Regulatory Compliance (ICH GCP), Cross-functional Collaboration
Preferred skills
Risk-Based Monitoring (RBM), Clinical Trial Lifecycle Management, Global Project Coordination
Technologies
Microsoft Office, Clinical Research Technology Systems
Responsibilities
Lead RBQM activities for assigned clinical studies; Develop and coordinate Central Monitoring Plans; Facilitate identification and tracking of KRIs and QTLs; Conduct centralized monitoring reviews to identify trends and risks; Recommend risk mitigation strategies; Maintain central monitoring dashboards; Provide training on RBQM principles; Support inspection readiness and regulatory compliance.
Seniority
Associate Manager, hands-on IC with team leadership