Clinical Study Lead (CTM II)
ICON plc
Summary
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.
Job description
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
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Requirements
- 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
- Legal right to work in the country where the role is based
Benefits
- Competitive base salary
- Performance related incentives
- Medical, Dental & Vision
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes
- Wellbeing resources
- Learning and development opportunities
Company overview
ICON plc is a global leader in clinical research and healthcare intelligence, founded in Dublin, Ireland in 1990. As one of the world's largest contract research organizations (CROs), ICON provides comprehensive outsourced development services to pharmaceutical, biotechnology, and medical device companies worldwide. The company operates in 55 countries with approximately 41,900 employees, offering end-to-end solutions that span the entire product development lifecycle. ICON's service portfolio includes clinical research services, adaptive trials, biosimilars, commercialization and outcomes consulting, medical imaging, laboratory services, and strategic support for traditional and digital health technologies. The company specializes in therapeutic areas such as oncology, cardiovascular diseases, central nervous system disorders, rare diseases, and women's health. With its 2021 acquisition of PRA Health Sciences, ICON significantly expanded its capabilities and market position, becoming a dominant force in the global CRO industry. The company is publicly traded on NASDAQ under the ticker ICLR and reported $8.28 billion in revenue for 2024.