Quality Control Analyst 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.

Our Configuration & QC Specialist supports the Project Management Team (PM) in configuring and QC’ing new studies in all ILS systems according to the specifications of 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.

The role:
• You will work closely with PM team in interpreting the CLW specifications and ensure information is clear and accurate for proper configuration into all systems, seeking guidance on any parameters that need clarification.
• Provide PM with configuration support by entering selected elements of the study’s specifications into the ILS systems.
• 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.
• Support PM in the creation of all configuration related forms such as Value Calculation Forms and the LIS Forms.
• Assist PM in preparing pdf documents for links to ICOLIMS and Read Only drive posting.
• When updates or additions are required for collection, packaging, shipping instructions or contact information to a study-specific Lab Manual or Requisitions, work with CS Leadership to determine whether or not those updates are warranted in the Lab Manual or Requisition Template and make those updates accordingly.
• 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.
• Perform level-appropriate quality checks on database and document updates for all amendments performed by PM.
• Verify and post documents for Read Only access once finalized, checking for adherence to version history and version control procedures.
• Provide technical support and guidance to PM for all study configuration tasks
• Performs additional relevant responsibilities as requested by management.

You will need:
• You will possess a BS or equivalent combination of experience and education and an understanding of client and site needs is a plus.
• You will have one year experience in Clinical Trials, Laboratory or similar database configuration work with knowledge of basic computer programs, excellent written communication skills, and the ability to manage multiple projects and exhibit appropriate time management skills.
• Self-starter with track record of well-developed learning strategies.
• Must be self-motivated and work well with various internal groups.

Salary Range: $50,448.00-$63,060.00

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.

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