Risk Surveillance Lead

ICON plc

Clinical Risk Surveillance Lead at ICON, responsible for driving RBQM practices within clinical trials. Aiding in risk assessment and management for trials in a global context.

Posted 6/18/2026full-timeRemote • 🇬🇧 United KingdomSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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/or issues
Facilitate risk review meetings and discussions with study / program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategies
Supports and participates in internal and external audits and inspection
Collaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach.

Requirements

What you’ll need

Bachelor’s Degree in a health-related, life science area, or equivalent combination of education, training, and work experience
Minimum of 6 years of experience in the pharmaceutical or CRO industry
Minimum of 2 years of experience in Risk Based Quality Management
Robust understanding of the drug development process and clinical trial execution
Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)
Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions
Knowledge of RBQM IT systems or other data analytic systems
Demonstrated ability to analyze data, identify patterns and make recommendations for improvement
Demonstrated ability to effectively lead cross functional team meetings
Experience forming cross-functional collaborations; strong interpersonal skills

Benefits

Comp & perks

Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

risk managementdata analysisroot cause analysismitigation strategiesCorrective Actions Preventive Actionsclinical trial executiondrug development processrisk assessmentquality tolerance limitsanalytics/visualizations

Soft Skills

interpersonal skillsleadershipcommunicationcollaborationfacilitationproblem-solvingteamworktraining supportdiscussion facilitationrecommendation making