Risk-Based Quality Manager

Job Summary

Supporting risk management and central monitoring activities, the full-time Risk and Central Monitoring Associate Manager will lead Risk-Based Quality Management (RBQM) initiatives for clinical studies, collaborating with cross-functional teams in a remote environment.

Key responsibilities

• Lead and oversee RBQM activities for assigned clinical studies
• Develop and maintain Central Monitoring Plans in alignment with study strategies
• Facilitate the identification and tracking of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs)

Required qualifications

• BSc, RN, or an equivalent combination of education, skills, and experience
• At least 4 years of clinical research experience, including 3 years with Risk-Based Monitoring (RBM)
• Prior experience as a Central Monitor or within a Central Monitoring function
• Strong understanding of RBQM principles and study risk assessments
• Demonstrated ability to analyze complex data and identify trends and risks