Clinical Risk Manager

Clinical Risk Manager - Global Studies - Mitigation Plans

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.

We are currently seeking a Clinical Risk Manager to join our diverse and dynamic team at ICON Plc. In this critical role, you will be responsible for coordinating and overseeing the execution of risk management for GCPM managed studies, (early, late and observational), globally. Oversee the quality of risk management for studies at a global level. Collaborates with cross functional stakeholders to ensure continuous, timeline and quality risk management.

What you will be doing

>Leading the Clinical Study Team to drive effective decision making for risk management

> Ensuring risk management implementation and conduct of studies in accordance with SOPs and ICH-GCP guidelines

> Responsible for CT.RACT completion and updates throughout the lifecycle of the clinical study

> Input to the development of the study protocol and functional plans

> Plan and lead high quality risk management discussions and reviews, including the identification and review of risks, critical data & critical processes

> Guide team on the process, requirements and how to complete the CT-RACT

> Review and ensure holistic quality (e.g. risk grading has sufficient rationale, not responsible to ensure inclusion of the appropriate study risks)

>Review adherence to timelines and requirements

> Responsible for feedback on risks to protocol development

> Support the development of risk mitigation strategies

> Lead reviews of mitigation effectiveness

> Analyze, summarize and report findings to inform future study design and library of mitigations

> Track and oversee completion of mitigation actions - progress reports to CST

> Provide advice on the development of functional plans

> Provide advice and input to functional plan updates - drive RBSE thinking

> Provide advice on linking risks to the standard KRIs, and identify study-specific KRIs

>Provide ongoing feedback for CT-RACT tool enhancements

>Support messaging, training and roll out of tool enhancements

> Extended member of the (G)CST: Agenda-driven attendance at Study Team meetings for topics of CT-RACT, Functional Plan reviews, KRI identification

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