The Clinical Risk Analyst is responsible for generating and translating study-level risk insights to enable proactive, data-driven decision-making across the conduct of clinical trials
Job Summary
The Clinical Risk Analyst is responsible for generating and translating study-level risk insights to enable proactive, data-driven decision-making across the conduct of clinical trials.
This role is a key driver of Risk-Based Quality Management (RBQM), leveraging centralized monitoring, analytics, and cross-functional data sources to identify, assess, and mitigate risks to patient safety, data integrity, and study delivery.
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer.
Matching Summary
The Clinical Risk Analyst is responsible for generating and translating study-level risk insights to enable proactive, data-driven decision-making across the conduct of clinical trials.
Skills & Requirements
Must-have
Risk-Based Quality Management (RBQM)
centralized monitoring
Key Risk Indicators (KRIs)
Quality Tolerance Limits (QTLs)
Root Cause Analysis (RCA)
ICH-GCP compliance
Nice-to-have
cross-functional data integration
continuous improvement of risk models
supplier oversight
cultural sensitivity
Key Requirements
Doctorate degree OR Master’s degree and 8+ years of clinical operations execution experience
8+ years work experience in life sciences or medically related field
3 years of biopharmaceutical clinical research experience
Experience working in global clinical trial teams
Experience with risk-based site monitoring
Experience with data-driven oversight in Risk Based Quality Management (RBQM) approaches