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)
CluePoints platform
Nice-to-have
strategic thinking and problem-solving
cross-functional collaboration
supplier/contractor oversight
inspection readiness
Key Requirements
Doctorate degree and 1 year of clinical operations execution experience
Master’s degree and 2 years of clinical operations execution experience
Bachelor’s degree and 4 years of clinical operations execution experience
Associate’s degree and 8 years of clinical operations execution experience
High school diploma / GED and 10 years of clinical operations execution experience
5 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 RBQM approaches
Knowledge of clinical regulatory requirements and guidelines