Principal CRA

As a Monitoring Oversight Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Oversight Monitoring Plan Development: Develop a comprehensive oversight monitoring plan tailored to our organization's specific clinical trials and research activities.
• Onsite and Remote Oversight Monitoring: Perform both onsite and remote oversight monitoring visits to assess protocol compliance, data accuracy, monitoring visit report review, and monitoring visit oversight.
• Quality Control and Risk Management: Implement quality control measures and risk management strategies to proactively identify and mitigate potential risks.
• Reporting and Recommendations: Prepare comprehensive oversight monitoring reports summarizing findings, recommendations, and corrective actions for management and regulatory agencies.
• Provide support for local partnerships with both internal and external stakeholders to enable the country focused delivery and execution of the R&D pipeline.
• Provide support for country level/cross study activities relating to local ‘sponsor’ relationships, oversight of CRO and country level performance, and provide local information, resource, and communication capabilities to maximize information flow in order to highlight and mitigate potential issues and efficiently resolve active issues.
• Perform country, site, and CRO sponsor oversight activities, to ensure high quality execution of clinical trials and highlight local opportunities to drive operational excellence.
• Maintain study information on a variety of databases and systems.
• Work with the strategic partner CRO, and global teams to provide required information as part of defined country and site selection processes.
• Support the maintenance of accurate contact lists, calendar information, local clinical operational intelligence and update tracking systems as needed.

You are:

• A minimum of 6 years of experience in onsite clinical monitoring and site management across multiple therapeutic areas.
• Excellent communication skills in English and other languages as needed per country.
• Previous participation in site audits and regulatory inspections preferred.
• Experience conducting co-monitoring and oversight visits with other CRAs.
• Abiltiy to travel on site potentially weekly

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.