As a Clinical Risk Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The Clinical Risk Specialist/Manager in the Development Operations Quality group will work under the direction of the Clinical Risk Lead to provide training on the Risk Based Quality Management and Central Monitoring processes to assigned clinical trial teams, collaborating with the functional department representatives across Development Operations to ensure proper training, process implementation and ongoing maintenance of risk management activities.

Summary of the Essential Functions of the Job:

• Develop and deliver Risk Based Quality Management processes and tools
• Lead the cross-functional study team in identifying critical to quality factors; studyspecific risks using the risk assessment tool and key risk indicators.
• Assist with the creation and maintenance of the project specific Quality Risk Management Plan
• Lead the cross functional study team through the risk assessment with the risk planning tool
• Support the study team in the development of functional study plan to manage identified risks
• Conduct periodic reviews of Risk Based Quality Management Plan as well as previously and newly identified risks.
• Communicate and coordinate risk identification and management activities with the cross-functional team on risks identified at specified timepoints.
• Develop and recommend risk mitigation strategies by working with the cross functional teams to document and escalate issues identified and develop and track strategies to mitigate them.
• Review study protocols as needed for areas of risk
• Have a good understanding of the systems/tools used for the process
• Leverage the process specific systems/ tools to support the study team to deliver the highest quality standards during the implementation.
• Contribute to process improvements for RBQM
• Stay informed on regulatory requirements for industry risk management
• May provide management of more junior members of the team

Minimum Requirements

• Undergraduate degree
• 3-5 years of relevant industry experience including 1 years of comprehensive Risk Based Quality Management concepts (RBQM and/or RBM process management)
• Strong written and verbal communications; proactive, critical thinker, task-driven, highly organized
• Strong knowledge of GCP, local regulations, global working environment and crossfunctional teams

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 maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.

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