Clinical Study Lead/CTMII

CTMII/Clinical Study Lead-United States-Remote

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are seeking a Clinical Study Lead (CTMII) to join our diverse and dynamic team. 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.

Your Profile

• Bachelor’s Degree in clinical, science, or health-related field (or licensed healthcare professional).

• 5+ years’ relevant experience, including 3+ years in clinical research leadership/ Project Management

• Experience Overseeing global studies

• FSP or Sponsor experience

• Expertise in oncology studies required

• Fluent English

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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 maximize 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 site to read more about the benefits ICON offers.

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 prote