Clinical Study Lead

About the Role ICON is seeking a Clinical Study Lead to oversee vendor relationships, budgets, timelines, and overall sponsor oversight across protocols/programs. The role emphasizes strong vendor/site relationships, deep protocol understanding, and collaboration across sponsor teams to drive site readiness and program success. What You'll Do

• Oversee vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) adherence to budget, timelines and program objectives for individual protocols.
• Develop and maintain strong vendor and site relationships, ensuring continuity through all trial phases.
• Attain in-depth understanding of the study protocol and procedures; contribute to study team knowledge by sharing best practices, recommending improvements, and providing training as appropriate.
• Coordinate tasks with other sponsor roles to achieve site readiness (e.g., study materials and approval for drug shipping/receipt).
• Perform timely review of monitoring reports from CRO and associated deliverables to demonstrate sponsor oversight.
• Periodically review CRO eTMF/TMF for adherence to standards and regulatory compliance.
• Work with vendors to revise scope of service agreements, budgets, plans and timelines, ensuring performance expectations are met.
• Support financial management of the study, including review and approval of site and vendor invoices.
• Support risk management initiatives.
• Support audit/inspection activities as needed.
• Maintain clinical trial registry entry/updates as required.
• Provide mentorship/guidance to junior team members or cross-functional colleagues on study processes and requirements. What We're Looking For
• Undergraduate degree or international equivalent in clinical, science, or health-related field; a licensed healthcare professional (e.g., registered nurse).
• 5 years of relevant experience including 3 years in clinical trial management.
• Fluent in English; fluent in language of host country.
• This is a hybrid role with office-based days in Warren, NJ or Armonk, NY or Cambridge, MA. Nice to Have
• (Not explicitly listed in the posting) Compensation & Benefits
• Competitive salary.
• Various annual leave entitlements.
• Health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings.
• Global Employee Assistance Programme, LifeWorks (24-hour access to a global network).
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
• Visit ICON's careers site for more benefits information.