Laboratory Study Start-Up Specialist

Laboratory Study Start-Up Specialist (Configuration & QC Specialist)

Farmingdale, NY

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 plays a key role within ICON Laboratory Services (ILS). Support 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.

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 tasks
• Performs additional relevant responsibilities as requested by management.

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.
• Self-starter with track record of well-developed learning strategies
• Must be self-motivated and work well with various internal groups

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

What's Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment