Monitoring Oversight Lead

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

The Monitoring Oversight Lead will be responsible for overseeing and ensuring compliance with site monitoring activities across all sites within the assigned region and/or country.

What you will be doing:

• Perform onsite and remote sponsor monitoring oversight visits as required.
• Perform review and trending of central monitoring findings as required.
• Support clinical trial teams in assessing and mitigating study level risks identified during monitoring activities
• Support clinical trial teams in managing issuesidentified during CRO monitoring activities
• Sponsor Monitoring Oversight Process Development & Process Improvement
• Perform routine monitoring compliance assessments across assigned studies (i.e., Monitoring Oversight process compliance) to ensure adherence to sponsor’s procedural documents and study plans.
• Support the Clinical Trial Teams with investigator site audit findings, responses, and follow-up asneeded.
• Review and analyze trends in investigator site audits to identify potential high-risk sites for monitoring oversight.
• Support the Clinical Trial Teams in the development and implementation of monitoring process corrective and preventative actions (CAPAs).

You are:

• Bachelor's degree in life sciences, healthcare, or a related field. Advanced degree preferred.
• Minimum of 6 years of experience in clinical research, with at least 5 years of direct onsite monitoring.
• Ability to travel, including internationally as necessary for monitoring oversight visits (approximately 40-50%).
• Direct experience managing investogator site audit findings, quality issues/events, and CAPAs.
• Proven experience drafing, and/or revising clinical operations procedural documents (i.e., SOPs, Forms, Templates, etc.) and study plans.
• Comprehensive understanding of global regulatory requirements and Good Clinical Practice (GCP).
• Advanced expertise in all data-driven monitoring and ability to collaborate internally and externally with investigators, site staff, and CRO monitors.

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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