06 sep
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Barcelona
RSL
ICON is a integral healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Title - Clinical Risk Surveillance Lead
Location - Must be based in the UK, Spain or Ireland (remote)
Sponsor dedicated
As a Clinical Risk Surveillance Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Working fully embedded within a growing, global program, you will be responsible for driving the adoption of RBQM practice at trial level and oversee the implementation, and continuous improvement. Risk Surveillance Lead works within a matrix environment and has overall accountability for the surveillance of the quality risks across the assigned trials and program, enabling a comprehensive clinical quality (GCP) risk governance.
What you will be doing:
• Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evalua-tion of risks based on likelihood, detectability, impact, and ensures mitigation strategy / plans are defined
• Responsible for drafting, maintaining, and archiving the study specific documentation of risk management activities
• Partners with the RBQM system configuration team to ensure risk indicators, quality tol-erance limits and other analytics/visualizations are programmed and functioning per op-erational requirements in the RBQM system
• Conduct of periodic central surveillance of the aggregate data at the study and program level, leveraging available analytics/visualizations in the RBQM system, to identify emerg-ing risks and/
📌 Risk Surveillance Lead (Barcelona)
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📍 Barcelona