Configuration & QC Specialist

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. 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.

What you 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.

Why join us?

Ongoing development is vital to us, and as a Configuration & QC Specialist you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin