ICON Clinical Research

Set Up Specialist

12 Jan 2021
11 Feb 2021
R & D , Laboratory
Full Time
Contract Type
Experience Level
Experienced (non-manager)
At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

The Set up Specialist I are responsible for the overall setup of a study of a clinical trial in respect to the central laboratory including lab specification gathering, hosting setup calls with sponsor, ensuring accurate database creation, and liaising with internal laboratory departments in order to setup a study in the time frame required to meet study milestones.

The role:
  • Own the Client Laboratory Worksheet (CLW) completion process. Ensure all information and specifications are captured in the Client Laboratory Worksheet (CLW) and are accurate by taking into account the study protocol, sponsor requests, ICON Laboratory standards, and requests/recommendations from internal operational groups.*
  • Working independently, coordinate and manage the completion of the Client Laboratory Worksheet (CLW) and communication of information as required to the other departments within ICON Laboratories (and ICON Clinical CRO if appropriate).*
  • Serve as the subject matter expert for the Sponsor in guiding them through a successful setup process by drawing on past experiences and standards. Highlight any risks associated with the study to the sponsor and internal parties including participating in internal risk assessment and other operational meetings as necessary.*
  • Communicate major decisions or timeline changes during setup with the Laboratory Project Manager and other laboratory staff as necessary (and ICON Clinical CRO if appropriate). Independently manage the laboratory setup timeline.*
  • Must have an in-depth knowledge of Laboratory database and how amendments to the database will affect different operational areas of laboratory and be able to efficiently anticipate and communicate these changes to all internal and external parties including sponsor clinical and data management teams.*
  • Present solutions and establish best practices for laboratory setups for new and complex protocol requirements.*
  • Lead projects in respect to setup process improvement and serve as a member for other projects utilizing subject matter expertise.
  • Contribute toward the maintenance of setup related documents such as the CLW template, Laboratory Manual template, Requisition template, and other items as necessary.
  • Serve as a resource in respect to the overall laboratory setup process for internal parties such as Project Management and the Laboratory.

What you need
  • Working familiarity with MS Word and Excel
  • Ability to multitask and perform effectively in spite of shifting priorities and workload
  • Prior relevant experience working in a clinical laboratory, clinical trials, project management or customer management/account management role in a life sciences related organization*
  • Bachelors degree or local equivalent