Clinical Risk Analyst Mgr.

Amgen UK

Hyderabad, India
On-site
Risk-based quality management (rbqm)
Centralized monitoring platforms (e.g., cluepoints)
Key risk indicators (kris) and quality tolerance limits (qtls)
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.
  • Lead centralized monitoring reviews using platforms such as CluePoints to drive risk identification, signal detection, trend analysis, and structured decision-making across assigned studies.

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 platforms (e.g., CluePoints)
  • Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs)
  • Root Cause Analysis (RCA)
  • Clinical trial processes and operations
  • ICH-GCP guidelines

Nice-to-have

  • Data-driven decision-making
  • Cross-functional collaboration
  • Continuous improvement of risk models
  • Global clinical trial experience

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
  • Experience using the Cluepoints platform

Work Rights

Not specified

Tailored Resume

Cover Letter