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 Set Up Specialist I (SUS) at ICON Central Laboratories (ICL), you will play a pivotal role in setting up the laboratory requirements of clinical trials.
Responsibilities
- Serve as the primary liaison with the client during the laboratory setup of the study.
- Own the laboratory specifications document completion process, ensuring accuracy 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.
- Work independently to coordinate and manage the completion of the Laboratory Specifications Document, timelines, and communication of information as required to other departments within ICL.
- Serve as a subject matter expert for the client, guiding them through a successful setup process, providing creative solutions, and highlighting any risks associated with the study.
- Oversee internal database configuration, client approval of site-facing Laboratory Manual and Requisitions, and source materials needed for the trial.
- Present solutions and establish best practices for laboratory setups for new and complex protocol requirements.
- Maintain accurate records and documentation related to Laboratory Specifications development activities.
Requirements
- Bachelor’s degree in a relevant field such as life sciences, clinical research, or healthcare management.
- 1+ years of experience working in a clinical trial environment.
- Experience interpreting study protocols, regulatory requirements, and GCP guidelines.
- Strong understanding of clinical trial processes and laboratory testing.
- Excellent organisational skills and attention to detail.
- Strong communication and interpersonal skills.
- Proactive attitude with a willingness to learn and adapt to evolving technologies and processes.
- Advanced English skills.
- Proficient in Microsoft Office Suite.
Benefits
- Competitive base salary and performance-related incentives.
- Health and wellbeing programmes.
- Retirement and pension plans.
- Life assurance and disability coverage.
- Employee assistance programmes and wellbeing resources.
- Learning and development opportunities.