Referral Laboratory Management Specialist I

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:

Lead and coordinate activities related to Referral Laboratory testing including but not limited to, evaluation of and on-boarding new Referral Laboratory vendors, coordinating execution and renewal of MSA’s with new lab vendors, assist with identifying appropriate laboratory and testing solutions at referral labs as per protocol requirements, reviewing referral lab quotations and organizing appropriately for inclusion in proposals and contracts. Operational activities related to technical study setup requirements – review of test code specifications, sample types/collection instructions, communicating risks or pending actions as applicable to internal stake holders, ensuring internal teams configure referral lab testing in database accurately, monitor pending results and results entry, mitigating related issues and queries that arise both internally and externally. Assist with holding regular operational calls with referral laboratories as well as coordinating technical calls with client and referral laboratories as required.

• Responsible for assisting with identifying new referral lab vendors as required to support specific protocols or for organizational needs. Manage onboarding of new referral laboratory vendors, coordinating execution of MSA and providing appropriate qualification (and surveillance) audit scope details to QA.
• Responsible for assisting with the selection of appropriate on-boarded/approved vendors to offer testing solution for new proposals and active studies. Reviewing quotations and organizing appropriately for billing (proposal or active study stage)., ,
• Evaluating test specifications and sample requirements, providing this detail to appropriate teams for database setup – assisting internal teams with study configuration requirements for referral laboratories. Ensuring all referral laboratory study setup documentation is in place with the referral laboratory vendor prior to study start.
• Responsible for quality monitoring of the referral labs. Including but not limited to the following: Managing result entry, ensure data delivery timelines and reporting expectations are metreview and asses referral lab test update requirements coordinate change needs with internal groups.
• Responsible for overseeing maintenance of the referral laboratory study setup tracker, procurement tracker for evaluating new referral laboratories and the Referral Laboratory master vendor list for MSA updates.
• Triaging and mitigating queries and issues raised by both internal teams and external customers. Working with the performing laboratory or internal departments for solutions. Assist with coordinating regular status update calls or escalations with performing laboratory as well as coordinating technical calls with the performing laboratory and clients as deemed necessary.
• Additional Administrative duties include; Scheduling and taking meeting minutes for internal and external clients, setting reminders for important dates and distribution of mail.
• Assists with creation and documentation of new processes in SOP format for the dept.

To be successful in the role, you will have:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Minimum of 3 year’s relevant experience and knowledge of clinical laboratory concepts and terminology. Knowledge or experience working with clinical trials is preferred.
• Proficient in the use of Microsoft Word, Excel, and Powerpoint
• Must have excellent oral and written communication skills to be able to effectively communicate with internal and external teams.
• Demonstrated ability to manage multiple tasks with good organization skills and good attention to detail.
• Ability to work in conformance with standard operating procedure and conditions with a systematic approach to tasks committed to seeing things through to completion.
• Action oriented demonstrating the ability to handle large work load demands and to trouble shoot issues timely when required.
• Customer Focused – providing timely, confident, reliable and friendly service to all our internal and external customers.
• Experience managing vendor-related activities (preferred)
• Familiarity with GCP Laboratory Regulatory Requirements (CAP, CLIA, NYS, others)
• Bachelors’ degree in Medical Technology or equivalent. 

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, please let us know through the form below.