Associate Director, Clinical Risk Management

Overview

In this role you drive cross-TA clinical risk management to protect trial data integrity and patient safety. You’ll work with trial and program teams to identify, assess, and mitigate quality risks, ensure regulatory compliance, and maintain inspection readiness. You’ll lead risk reviews, advise teams on mitigation, and support CAPA and quality investigations. This position offers impact across international programs within a global quality organization and opportunities to shape risk-based oversight.

Responsibilities

• Identify and assess key risks in clinical protocol/setup and advise on mitigation strategies
• Lead regular risk review meetings with Risk Owners to track mitigations and new risks
• Maintain Clinical Quality Plans (CQP) in a quality repository and monitor progress
• Drive quality risk monitoring reviews and coach others on risk reviews
• Communicate risk updates to R&D colleagues via Quality Working Groups and Governance Fora
• Provide guidance on significant quality issues (SQI) per corporate standards and escalate as needed
• Collaborate on corrective and preventive action (CAPA) plans and effectiveness checks
• Support inspection readiness activities including developing narratives and coordinating mock inspections
• Provide independent advice on research quality and regulatory interpretation with cross-functional teams
• Participate in cross-R&D and cross-sector groups to develop and refine processes, tools, and systems
• Provide training and coaching to peers and new employees

Key requirements

• Bachelor’s degree in scientific, medical, or related discipline
• 8+ years in healthcare/pharmaceutical industry or CRO/healthcare setting
• Strong GCP quality and/or clinical trials experience
• Excellent interpersonal, verbal, and written communication
• Ability to adapt to changing business needs and work across diverse global teams
• Proficiency in Microsoft Office
• Experience with clinical trial risk management and ICH guidelines
• Knowledge of GMP, GLP, and/or GPvP preferred
• Health Authority inspection experience (FDA, EMA, etc.) required
• Project planning/management skills; CAPA and escalation experience preferred
• Data analytics and/or data visualization experience (Tableau, Spotfire) preferred
• English proficiency; travel up to 10%

• strong communication
• cross-functional collaboration
• adaptability
• GCP quality in clinical trials
• ICH guidelines
• GMP/GLP/GPvP knowledge

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