Clinical Risk Management Director

Job Summary

A company is looking for an Associate Director, Clinical Risk Management and Process Improvement.

Key Responsibilities

• Utilize a data-driven approach to identify, assess, and mitigate risks in clinical studies
• Collaborate with teams to design and implement risk-based monitoring and data analytics strategies
• Evaluate clinical operational processes to identify inefficiencies and propose improvements

Required Qualifications

• Bachelor's degree (Master's preferred) with 8+ years of experience in clinical study operations
• Deep understanding of ICH-GCP and regulatory requirements, with experience in RBQM methodologies
• At least 2 years of process improvement experience managing projects and establishing performance metrics
• Knowledge of data-driven methodologies such as Lean Six Sigma or Kaizen
• Proven ability to manage complex projects and lead cross-functional teams