Configuration & QC Spec I

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role: Configuration & QC Spec I

To be successful in the role, you will have:

Configuration & QC Spec I

The role: will consider remote candidates
* 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 knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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.