Configuration & QC Spec I

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.

How about becoming part of the ICON Laboratory Services (ILS) Central Laboratory Setup team where you will use your expertise to build trial specific study databases and all study related material such as Laboratory Manuals and study requisition forms. This position will give you a unique perspective into the ever important setup phase of a clinical trial including - being exposed to different study phases, study sizes and disease indications all while being a hands on participant in the building and creation of the trial.

The role:

This role is to support the Project Management Team (PM) in configuring and QC'ing new studies in all ICL systems according to the specifications on the Client Laboratory Worksheet (CLW) and create all supporting documents and site instructions to facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables, and study specific Lab Manuals.

This would be an excellent opportunity for candidates with 2 to 3 years of experience in lab clinical research with LIMS experience and good analytical and logical skills.

This Role requires to cover shift timing from 03:00 PM to 12:00 AM

Job Description

Work closely with the PM team in interpreting the CLW specs and ensuring that all is clear and accurate enough for proper configuration into all systems, seeking guidance on any parameters that need clarification.

• The Configuration/QC Specialist will be support the Project Management Team (PM) in configuring and QC'ing new clinical studies in all ILS systems according to the specifications of the Client Laboratory Worksheet (CLW).
• You will create supporting documents for the site to facilitate proper specimen collection, coordinate packaging and shipping including visit requisitions, reference range tables, and study specific Lab Manuals and collection guides.
• Ensure information is clear and accurate and seek guidance on any parameters that need clarification. When updates or additions are requested the Configuration/QC Specialist will work with Leadership to determine whether those updates are warranted in the Lab Manual or Requisition Template and make those updates accordingly.
• The Configuration/QC Specialist will perform new study configuration quality checks on all databases, internal forms and supporting documents to ensure high quality output and adherence to the CLW specs and provide technical support and guidance to Project Managers for all study configuration tasks.

You will need:

• University degree in medicine, science or equivalent
• *Previous monitoring experience in medium sized studies, including study start-up and close-out
• Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
• Excellent written and verbal communication
• Ability to work to tight deadlines

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.