Clinical Risk Analyst Mgr.

Amgen

Fully remote
Master's degree or doctorate
8+ years clinical operations experience
Risk-based quality management (rbqm)
The role is responsible for generating study-level risk insights to enable proactive, data-driven decision-making across clinical trials

Job Summary

  • The role is responsible for generating study-level risk insights to enable proactive, data-driven decision-making across clinical trials.
  • Candidates must lead centralized monitoring reviews using platforms like CluePoints to drive risk identification and signal detection.
  • This position plays a critical part in connecting study-level risk signals to broader program and portfolio risk perspectives.

Matching Summary

The role is responsible for generating study-level risk insights to enable proactive, data-driven decision-making across clinical trials.

Skills & Requirements

Must-have

  • Master's degree or Doctorate
  • 8+ years clinical operations experience
  • Risk-Based Quality Management (RBQM)
  • Centralized monitoring expertise
  • CluePoints platform proficiency
  • Key Risk Indicators (KRIs) definition
  • Root Cause Analysis (RCA)

Nice-to-have

  • Global clinical trial team experience
  • Strategic thinking and problem-solving
  • Cross-functional collaboration skills
  • Supplier oversight experience
  • Cultural sensitivity in global teams

Key Requirements

  • Doctorate OR Master's degree with 8+ years experience
  • 3+ years biopharmaceutical clinical research experience
  • Experience with Phase 1-3 interventional trials
  • Proficiency in CTMS, eTMF, and EDC systems

Work Rights

Not specified

Tailored Resume

Cover Letter