Set Up Specialist

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

We are currently seeking a Set Up Specialist I (SUS) to join our diverse and dynamic team. As a SUS at ICON Central Laboratories (ICL), you will play a pivotal role in setting up the laboratory requirements of clinical trials. You will contribute to the advancement of innovative treatments and therapies by facilitating efficient study setup processes in relation to compliance with study protocols, timelines, operational requirements, and client expectations.

What You Will Be Doing:

• Serve as the primary liaison with the client during the laboratory setup of the study.
• Own the laboratory specifications document completion process. Ensure all information captured in the Laboratory Specifications Document and are accurate by considering the study protocol, client requests, ICL standards, and requests/recommendations from internal operational groups.
• Communicate major decisions or timeline changes during setup with the ICL Project Manager and other ICL staff as necessary (and ICON Clinical CRO if appropriate).
• Work independently to coordinate and manage the completion of the Laboratory Specifications Document, timelines and communication of information as required to the other departments within ICL (and ICON Clinical CRO if applicable).
• Serve as subject matter expert for the client, guiding them through a successful setup process, providing creative solutions by drawing on past experiences and/or ICL standards. Highlight any risks associated with the study to the client and internal parties including participating in internal risk assessment and other operational meetings as necessary.
• Oversee internal database configuration, client approval of site-facing Laboratory Manual and Requisitions based on the Laboratory Specifications Document, and source materials needed for the trial that are required for visit specific kits to sites.
• Present solutions and establish best practices for laboratory setups for new and complex protocol requirements.
• Maintaining accurate records and documentation related to Laboratory Specifications development activities.

Your Profile:

• Bachelor’s degree in a relevant field such as life sciences, clinical research, or healthcare management.
• Strong understanding of clinical trial processes and laboratory testing.
• Experience interpreting study protocols, regulatory requirements, and GCP guidelines.
• Excellent organizational skills and attention to detail, with the ability to manage multiple setup tasks simultaneously.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse teams and stakeholders.
• Proactive attitude with a willingness to learn and adapt to evolving technologies and processes.
• 1+ years of experience working in a clinical trial environment such as project management, site coordination, or database configuration, etc.
• Proficient in Microsoft Office Suite; Word, Excel, PowerPoint

What ICON can offer you:

Visit our careers site 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.

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