Clinical Study Lead (CTM II)

ICON; Northern (KY); Hybrid; USD 95,000 - 150,000; Full time

Job summary

ICON Strategic Solutions is recruiting for a Clinical Trial Manager II to support sponsor-dedicated projects across multiple sites in the US. You'll oversee vendor performance, manage budgets and timelines, and mentor junior staff while ensuring compliance with study procedures and regulatory requirements.

The role requires an undergraduate degree in a clinical or health field, at least five years of relevant experience (three in CTM), and fluent English.

Qualifications

• Undergraduate degree in clinical, science or health related field.
• 5 years of relevant experience including 3 years of clinical trial management.
• Reads, writes and speaks fluent English; fluent in language of host country.

Responsibilities

• Vendor oversight for adherence to budget, timelines, and objectives across protocols/programs.
• Develops strong vendor and site relationships throughout all trial phases.
• Ensures study protocol understanding and trains team on processes and improvements.

Skills

Clinical trial management experience

English fluency

Education

Undergraduate degree in clinical/science/health field

Job description

Clinical Trial Manager II (Warren, NJ, Armonk, NY or Cambridge, MA)

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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

• 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 including 3 years of experience in clinical trial management

• Reads, writes and speaks fluent English; fluent in language of host country.

• This is a hybrid role - office based three days per week in Warren, NJ, Armonk, NY or Cambridge, MA

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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

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, 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 or submit a request here