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.
The role plays a critical part in connecting study-level risk signals to broader program and portfolio risk perspectives, maintaining a strong partnership with Associate Directors of Risk Management to ensure visibility, alignment, and aggregation of emerging trends.
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
problem-solving abilities
collaboration across global teams
curiosity and willingness to take on new tasks
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