Clinical Study Lead (CTM II)

ICON Clinical Research; New Jersey; Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee assistance program

Life insurance

Flexible benefits

Job summary

ICON Strategic Solutions is seeking a Clinical Trial Manager II for a hybrid role with offices in Warren, NJ, Armonk, NY, or Cambridge, MA. You will oversee vendor relationships, budgets, and timelines across sponsor-dedicated trials, while ensuring protocol adherence and sponsor oversight.

The ideal candidate has 5 years of trial experience, including 3 years in trial management, and fluent English. This role combines field responsibilities with office-based collaboration three days per week.

Qualifications

• Undergraduate degree in clinical, science, or health-related field.
• 5 years of relevant experience including 3 years in clinical trial management.
• Fluent in English (reads, writes, speaks).

Responsibilities

• Oversee vendor oversight for budgets, timelines and objectives of protocols/programs.
• Develop and maintain strong vendor/site relationships across trial phases.
• Understand study protocol and procedures to share best practices and train others as needed.
• Coordinate tasks with sponsor roles to achieve site readiness and drug shipping approvals.
• Review monitoring reports from CRO to ensure sponsor oversight is timely.
• Review CRO eTMF/TMF to ensure compliance with regulations.
• Negotiate scope of service, budgets and timelines with vendors.
• Support study finances including approval of site and vendor invoices.
• Support risk management initiatives for the study.
• Assist with audit/inspection activities as needed.
• Maintain clinical trial registry entries as required.
• Mentor junior team members and cross-functional colleagues.

Skills

Clinical trial management

Vendor management

Budget & timelines

Cross-functional collaboration

English fluency

Education

Undergraduate degree in clinical/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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations)