Clinical Study Lead (CTM II)

ICON Strategic Solutions is a sponsor-dedicated clinical research organization providing expertise and support to pharmaceutical and biotechnology sponsors. The Clinical Trial Manager II oversees vendors, sites, study processes, budgets, timelines, documentation, risk management, and audit activities across clinical trials while mentoring junior team members.

Responsibilities

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

Benefits

Hybrid role - office based three days per week in Warren, NJ, Armonk, NY or Cambridge, MA

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

Career development

Company

Outsourced clinical development and commercialization services for life sciences

Dublin , GB

https://www.iconplc.com/services/strategic-solutions/

10001+ employees

Qualifications

• 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

Required skills

Represents the skills you have, click on the tags, Registered Nurse

Experience

5+ years