Description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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.
Responsibilities
- 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
Rewards & Benefits
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways