Clinical Study Lead

ICON; New Jersey; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee Assistance Programme

Flexible optional benefits

Job summary

ICON in the United States is seeking a Clinical Study Lead to drive the success of clinical trials through effective vendor oversight and management. The ideal candidate will hold an undergraduate degree in a relevant field and have at least 5 years of related experience, including 3 years in clinical trial management.

ICON values diversity and offers a competitive salary along with a range of benefits, including health insurance, retirement planning, and annual leave entitlements. Join us to help shape the future of clinical development.

Qualifications

• 5 years of relevant experience including 3 years in clinical trial management.
• Fluent in English and the local language.

Responsibilities

• Oversee vendor adherence to budget and timelines.
• Develop strong relationships with vendors and sites.
• Maintain clinical trial registry updates.

Skills

Clinical trial management

Vendor oversight

Mentorship

Risk management

Budget management

Education

Undergraduate degree in clinical or health-related field

Licensed healthcare professional (e.g., registered nurse)

Job description

Clinical Study Lead - Regeneron

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.

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.

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.

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.