Risk Surveillance Lead
ICON plc
full-time
Posted on:
Location Type: Remote
Location: Ireland
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Job Level
Tech Stack
About the role
- 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), evaluation 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 tolerance limits and other analytics/visualizations are programmed and functioning per operational 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 emerging 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
- 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
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
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