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In this role you drive risk-based quality oversight for clinical trials and programs, ensuring data integrity and patient safety. You collaborate with trial and program teams to identify, assess, and mitigate quality risks, maintaining inspection readiness and regulatory compliance. You will lead risk reviews, guide CAPA efforts, and support global quality governance. This position offers cross-country impact within a mission-driven healthcare innovator and a chance to shape trial quality at scale.
Compensaciones / Beneficios
• Identify and assess key risks in study protocols and trial setup; advise on mitigation strategies for complex trials
• Lead regular risk-area reviews with Risk Owners to monitor mitigations and identify new risks
• Maintain Clinical Quality Plans (CQP) in the quality repository and monitor quality support services
• Drive quality risk monitoring reviews and coach others on risk assessment
• Communicate risk updates to Ru0026D colleagues through Quality Working Groups and governance forums
• Escalate systemic risks to RDQ CRM management and guide investigation of quality issues
• Support CAPA development and effectiveness checks with partners in RDQ
• Lead ongoing inspection readiness activities, including mock inspections and site preparation
• Provide support for inspections and post-inspection activities; advise on research quality and regulatory interpretation
• Contribute to cross-functional groups to refine processes, tools, and systems for innovative quality solutions
• Provide training and coaching to peers and new hires
Responsabilidades
• Bachelor in scientific, medical, or related discipline
• Minimum 8 years' healthcare/pharma/CRO experience
• Strong GCP quality and/or clinical trials experience
• Excellent interpersonal, oral, and written communication
• Flexibility t
📌 Associate Director, Clinical Risk Management (Madrid)
🏢 Johnson u0026 Johnson
📍 Madrid
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