Configuration &QC Spec I - #1757843

ICON plc

Date: 05/10/2021
City: Farmingdale, NY
Contract type: Full time
ICON plc

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: Laboratory Database Setup Specialist - Farmingdale NY- open to remote

To be successful in the role, you will have:

As a global provider of drug development solutions, our work is serious business. That does not mean you cannot 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.

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


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