Clinical Development Risk & Compliance Manager
Remote · South Korea
Job Summary
Senior Clinical Development Risk & Compliance Manager responsible for leading risk management across assigned projects/accounts, guiding cross-functional teams and SMEs in identifying, prioritizing, and mitigating risks; driving QRE-based analysis, embedding mitigation into project strategy, and providing strategic, real-time guidance to leadership. Focus areas include ICH-GCP compliance, CAPA development and effectiveness, audit/inspection readiness, SOP governance, and knowledge-sharing through lessons learned. Travel up to 15-20% to support audits, client interactions, and project needs. Strong leadership, data-synthesis, and stakeholder-management skills are essential to deliver first-time quality and sustained risk control across multi-project accounts.
Required Qualifications
- Bachelor’s Degree in life sciences or health-related discipline (required)
- 8-12 years’ experience in clinical research
- Experience in Quality or Risk Management activities
- Expertise in root cause methodologies and CAPA development
- Fluency in written and oral English; additional languages an asset
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