Set Up Specialist

Job Title: Set Up Specialist I

Location: Leopardstown, Dubbin 18

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?

At ICON, we have an incredible opportunity for a Set Up Specialist I to join the team in our Leopardstown, Dublin 18 location.

The Role:

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 timeframe required to meet study milestones.

• Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Serve as the primary liaison with the sponsor during the setup phase of the study
• 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.

What you will need:

• Bachelors degree or local equivalent, preferably Science related
• Prior relevant experience working in a clinical laboratory, clinical trials, project management or customer management/account management role in a life sciences related organization
• Working familiarity with MS Word and Excel
• Excellent oral and written communication skills
• Ability to multitask and perform effectively in spite of shifting priorities and workload