ICON is a global 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.
Risk Surveillance Lead
Location
United Kingdom
Posted
3 days ago
Salary
0
Seniority
Senior
Job Description
Risk Surveillance Lead
ICON plc
• 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.
Job 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
- 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
Related Guides
Related Categories
Related Job Pages
More Risk Jobs
• Mapear, documentar e otimizar processos operacionais, identificando gargalos, riscos e oportunidades de melhoria. • Construir, acompanhar e analisar indicadores de desempenho das áreas da Diretoria de Operações. • Desenvolver dashboards e relatórios gerenciais para suporte à tomada de decisão. • Apoiar projetos de transformação operacional, automação e ganho de eficiência. • Conduzir análises de causa raiz e acompanhar planos de ação para resolução de problemas recorrentes. • Estruturar e sustentar ritos de governança operacional, consolidando informações para fóruns de acompanhamento e gestão. • Atuar em parceria com diferentes áreas da operação, apoiando lideranças na gestão de performance e alinhamento de processos.
Purview Specialist
BlueVoyantBlueVoyant is a cloud-native cyber defense platform that delivers positive security outcomes that drive business results. The company converges external and int
Role Description BlueVoyant is currently seeking a Purview Specialist to join Deployment Engineering, Microsoft Data Security & Compliance in our Deployment Services team. In this role, you will leverage your knowledge of Microsoft Purview and Compliance technologies to enable comprehensive data security solutions within customer environments. You will work on projects focused on data protection, classification, and compliance across small, medium, and enterprise-sized organizations, involving hands-on deployment of Microsoft Purview and related compliance solutions. - Work on Microsoft Purview and Compliance complex project implementations for customers (remotely), including design, architecture, deployment, and use case optimization. - Implement and configure data security solutions focusing on Data Classification, Microsoft Information Protection, Data Loss Prevention, and Insider Risk Management. - Create and develop new data protection policies, automation workflows, and compliance reporting per customer requirements. - Assess and report maturity of client data security and compliance deployments. - Define and assist in creating operational and executive compliance reports and dashboards. - Participate in research and development activities for process improvement and new product/feature enhancements. - Work on integration activities across Microsoft Purview and the broader Microsoft 365 compliance ecosystem. - Serve as a technical delivery resource for client-facing projects. - Collaborate with and support other engineers on the team. - Participate in ongoing support activities for managed service customers to help mature and maintain data security practices. - Identify and implement improvements around process and technical enablement. - Contribute to knowledge sharing activities, such as internal documentation, lunch and learn sessions, and public-facing blogs. - Support pre-sales activities by providing technical expertise, project scoping, and demonstrations of Microsoft Purview capabilities. Qualifications - 3+ years of technical experience enabling security and compliance technologies. - Strong experience with Microsoft Purview, including Data Classification, Information Protection, Data Loss Prevention (DLP), and Insider Risk Management. - Experience with Microsoft 365 Purview Center administration and configuration. - Knowledge of data governance principles within the Microsoft ecosystem. - Hands-on experience implementing sensitivity labels, retention policies, and DLP rules. - Experience with compliance query languages and/or scripting (e.g., PowerShell). - Excellent communication skills for client engagement and teamwork. - Current Microsoft certifications related to compliance and security (or willingness to obtain within 90 days). Requirements - Microsoft Certified: Information Protection Administrator Associate, Security Administrator Associate, or equivalent. - Understanding of Zero Trust principles as applied to data security. - Experience with risk assessment methodologies and compliance reporting. - Proficiency in PowerShell scripting for compliance automation. - Experience across all Microsoft Purview workloads. - Knowledge of regulatory frameworks (e.g., GDPR, HIPAA, CCPA) and implementation using Microsoft tools. - Customer-facing consulting experience. - Expertise in Microsoft 365 E5 Data Security & Compliance features. - Experience integrating Microsoft Sentinel for compliance monitoring. Company Description BlueVoyant is an AI-driven cybersecurity company dedicated to standing between our customers and cyber threats. By combining human, artificial, and proprietary intelligence, we deliver a unified solution that protects every organization’s network, identities, vendors, and digital footprints as a single attack surface. The company’s award-winning Microsoft Security expertise helps organizations maximize their security investments while reducing risk and ensuring compliance. Founded in 2017 by Fortune 500 executives, BlueVoyant is headquartered in New York City and has offices in Maryland, Tel Aviv, San Francisco, London, Budapest, and Latin America.
• Supports the business/group leader in implementing, maintaining, and administering first line of defense programs • Ensures adherence and efficiency in oversight of business operations • Contributes to a risk management culture through collaboration with first line employees and risk functions • Acts as a strategic partner ensuring program elements integrate with overall business/group strategies • Develops expert understanding of business/group challenges • Prepares and briefs senior leaders on regulatory matters • Monitors and advises on risk requirements within defined risk appetite. • Tracks performance and addresses issues, leading change management programs.
Vice President of Risk Intelligence – Logistics and Transportation
Keller Executive Search InternationalTransforming Organisations with Exceptional Leadership
• Work directly with insured clients to review how they actually run their business • Assess their Standard Operating Procedures (SOPs) and confirm they are clearly written, properly put in place, and followed in practice • Find the gaps between what should happen and what does happen, then drive the fixes • Tie that work to measurable results: fewer losses, fewer claims, stronger client performance • Advise the underwriting team using what you learn in the field • Build the Risk Intelligence department over time, with your first hire expected within about a year • Lead the Risk Intelligence function from the ground up • Design repeatable processes, SOP audit frameworks, and an enterprise risk management (ERM) approach the company can scale • Conduct client reviews and operational assessments, mostly by video call, some on site • Check how well each insured vets and onboards motor carriers (safety, financial standing, licensing, insurance) and where their compliance checklists break down • Give clients clear, practical recommendations to tighten safety and compliance • Partner with underwriting to sharpen risk selection, and with claims to spot loss trends and prevent repeat losses • Act as a trusted advisor who raises the operational maturity of the clients you serve • Help define how the department and team grow over the next several years



