Set Up Specialist - Clinical Trial Laboratory Setup

About the role

ICON is a global healthcare intelligence and clinical research organisation. It is looking for a Set Up Specialist I (SUS) to join its Central Laboratories team in Sofia. The SUS sets up the laboratory requirements of clinical trials, ensuring efficient study setup in line with study protocols, timelines, operational requirements and client expectations.

Key responsibilities

• Serve as the main point of contact with the client during laboratory setup of the study.
• Own the completion of the Laboratory Specifications document, making sure the information is accurate and reflects the study protocol, client requests, ICL standards and internal recommendations.
• Communicate major decisions or timeline changes with the ICL Project Manager and other staff, and with ICON Clinical CRO where appropriate.
• Coordinate and manage the Laboratory Specifications document and timelines independently, and share information with other ICL departments.
• Act as subject matter expert for the client, guide them through setup, highlight risks and take part in internal risk assessments and operational meetings.
• Oversee internal database configuration, client approval of the site-facing Laboratory Manual and Requisitions, and the source materials needed for visit-specific kits.
• Present solutions and best practices for laboratory setups, especially for new and complex protocols, and keep accurate records of Laboratory Specifications development.

Required profile

• Bachelor's degree in a relevant field such as life sciences, clinical research or healthcare management.
• 1+ years of experience in a clinical trial environment, such as project management, site coordination or database configuration.
• Strong understanding of clinical trial processes and laboratory testing.
• Experience interpreting study protocols, regulatory requirements and GCP guidelines.
• Excellent organisational skills, attention to detail and strong communication and interpersonal skills.
• Legal right to work in the country where the role is based.

Required skills

• Proficiency in Microsoft Office Suite: Word, Excel, PowerPoint.

What we offer

• 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 learning and development opportunities.