Risk Surveillance Lead

Risk Surveillance Lead

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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/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.

You are:

• 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

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply