Configuration & QC Spec I

Configuration & QC Specialist

A 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?

Our Configuration & QC Specialist plays a key role within ICON Laboratory Services (ILS) and will support the Project Management Team (PM) in configuring and QC'ing new studies 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.

Overview of 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 task

Role Requirements

• 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.