Clinical Study Lead

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

What you will be doing:

• Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines and organizational objectives of individual protocols/programs.
• Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.
• Obtains and maintains in-depth understanding of the study protocol and related procedures in order to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure.
• Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight.
• Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
• Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
• Supports financial management of the study which includes review and approval of site and vendor invoices.
• Supports risk Management initiatives
• Supports audit/inspection activities as needed.
• Maintain clinical trial registry entry/updates, as required.
• Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements

You are:

• Undergraduate degree or its international equivalent preferably in clinical, science, or health related field from an accredited institution; a licensed health-care professional, i.e., registered nurse
• 5 years of relevant experience
• Minimum 3 years of experience in clinical research, including a management role as a team lead or project manager experience.
• Experience managing oncology/hematology studies
• Experience managing outsourced studies (FSP/Sponsor)
• Reads, writes and speaks fluent English; fluent in language of host country.
• Experience in oncology studies is required

• Must be open to hybrid office/home based in Warren NJ or Armonk NY

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, 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, colour, 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.