Set Up Specialist - Labs - Clinical Trials

ICON Plc is an Irish success story. The company started with 5 original members in Dublin back in 1992. We are now over 14,000 permanent team members based in a state of the art facility in Leopardstown with over 800 people on-site. We are a contract research organization. Contract research organisations are companies who develop therapies to pro-long life & increase quality of life. We are one of the most hi-tech & biggest in the world operating across 97 countries. We have on-site laboratories in our HQ in Dublin. We also have a subsidized canteen & coffee shop

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.

Set Up Specialist role within ICON:

Selected to coordinate clinical trial start-up activities and serve as primary contact for investigators and research coordinators in corporate sponsored human clinical trials.

• Recognize, exemplify and adhere to ICON's values which center 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.
• Serve as a resource in respect to the overall laboratory setup process for internal parties such as Project Management and the Laboratory.
• Travel (approximately 2%) domestic and/or international.

ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a phenomenal career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart. Other than working with a great team of switched on and ambitious people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career. ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.