Set Up Specialist

Currently looking a Set Up Specialist for our Farmingdale NY location.

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

The role

• 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.

What you need

• The successful applicant will have a background of working on clinical trials. This will be in a laboratory, clinical trials or project management within the pharmaceutical industry.

• Most of the team hold a BA or BSc in Life Sciences or a related area of expertise.

• Our team members have working knowledge of MS Word, Excel and PowerPoint.

• Possess the ability to multitask, remain composed and even-keeled in stressful situations, and perform effectively in spite of shifting priorities, workload and external pressures.

• If you have 2+ years of working in this environment we would love to hear from you.

Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.