Lead Clinical Oversight Manager - Home-Based (US)

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

The primary responsibility of the Lead COM is to ensure adequate sponsor oversight of the conduct, monitoring and management of one or more clinical studies and assigned monitors at clinical study sites, within the assigned country or region.

• Contributes to development of the Overall Study Management Plan, the study level Site and Monitoring Plan and the Oversight Monitoring Plan.
• Contributes to the definition of appropriate standards and quality indicators for site management and monitoring.
• Ensures high quality conduct and execution of clinical studies at sites according to the protocol and study team and governance requirements in compliance with quality, regional and regulatory (GCP) standards.
• Addresses issues identified with study conduct, monitoring and site management with Sponsor’s management, are appropriately communicated/escalated and follows up through resolution.
• May conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities per applicable study plans, as needed.
• Reviews the submission documents for IRBs/IECs and Health Authorities as appropriate for assigned sites/countries/region.
• May assist with translations or verification of translations.
• Implements approved communication plans with external strategic partners or CROs.
• Supports the collection of key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality.
• Reviews monitoring visit reports for finalization/consistency/issues according to study monitoring plan.
• Utilizes available tools/systems to assess vendor and site performance.
• Ensures inspection readiness at the study sites and follow up corrective/preventive actions.
• Maintains good communication and working relationships with investigators, internal stake-holders and external services providers (CROs).
• Provide input into study feasibility for assigned sites/countries/region and supports the on-time delivery of a clinical study data, globally (if applicable)

• A degree (BSc/MSc or equivalent preferred) in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area.
  • Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
• Minimum of 8+ years’ relevant clinical research (or related) experience.
• 6+ years’ experience in monitoring and site management of industry sponsored clinical research (CRA, Clinical Trial Monitor, or equivalent).
• A thorough understanding of the drug development and clinical trial process.
• The ability to assess selected CROs monitoring performance and provide constructive feedback and remediation as necessary.
• The ability to participate in preparation, conduct and follow up of audits and site inspections.
• Active management experience of countries and sites in a region

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.