Central Review Coordinator

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:

This role as Central Review Coordinator offers the right candidate the opportunity to join the Central Review Services team; unique in the CRO industry. The team is solely focused on delivering independent, centralized endpoint data evaluation, grading, and data management for SLE clinical and laboratory endpoints including: BILAG; SLEDAI; SLEDAI Flare Index; SLICC; and other assessment tools. This central review process produces a higher level of accuracy and decreased variability that is essential in endpoint measurement and analysis.

Responsibilities in the position will include:

• Create and maintain Study Trackers.
• Monitor screening deadlines; follow up with sites on data entry and other vendor data entry and escalate any visits that are not released for CR review or where queries are not being addressed within the timelines.
• Review and determine on study visits and sweeps are ready for review using the page status and query reports.
• Create, send and process assignments to reviewers, including query tracking.
• Download and compile files for the patient profile creation and post on the Central Grading Portal for the Data Programmer, CRS.
• Create internal CRS agenda and meeting minutes for distribution
• Action/Decision log updates/maintenance
• Filing of documents in Central Grading Portal and eTMF.
• Liaise with Directors, Therapeutic Expertise, internal team members and Sponsors.
• Performs proficient reviews of study datasets prior to client transfer, if applicable.
• Monitor review progress to meet timelines, identify issues, risks, possible solutions & report to Lead Central Review Manager.
• Participates in database lock activities.
• Serve as CR Coordinator on more or more projects.
• Other duties as assigned.

To be successful in this position you will have:

• BSc Life Science degree with solid experience working within a CRO and or the pharmaceutical industry
• Prior experience as a Data Coordinator
• Strong experience with at least one of the data management systems
• Experience in most study tasks
• Comfortable working within a project team and have excellent written and verbal communication skills
• Experience in Microsoft Word and Excel
• Strong attention to detail
• Effective time management and prioritization skills

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.

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