Central Review Coordinator
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
This role as Central Review Coordinator offers the right candidate the opportunity to join the Central Review Services team; which is 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. This central review process produces a higher level of accuracy and decreased variability that is essential in endpoint measurement and analysis.
Responsibilities 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.
You will have/be:
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 i.e. Rave
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
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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
