Associate Manager, Centralized Monitoring

Job description

Position Summary: The Associate Manager, Centralized Monitoring is responsible for executing and overseeing centralized monitoring activities across clinical trials using a risk-based quality management (RBQM) framework. The role focuses on proactive signal detection, data surveillance, risk identification support, and escalation to support study quality, participant safety, and regulatory compliance. This position also contributes to process improvement, and cross-functional collaboration related to centralized monitoring activities. Incumbent will support cross-functional collaboration across multiple clinical studies, with a focus on regulatory compliance and inspection readiness. Essential Job Functions and Responsibilities: These may include but are not limited to: - Support the execution of centralized monitoring strategies for studies ensuring setup aligns with Crinetics’ RBQM best practices. - Perform ongoing centralized monitoring reviews using clinical, operational, and quality data sources (e.g., EDC, CTMS, safety, vendor data). - Identify emerging study-level and site-level risks through Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and analytical outputs...