[Hiring] Central Review Coordinator @ICON plc

Role Description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

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 one of our Big Pharma FSPs. This central review process produces a higher level of accuracy and decreased variability that is essential in endpoint measurement and analysis.

• 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.

Qualifications

• BSc Life Science degree with solid experience working within a CRO and or the pharmaceutical industry.
• A genuine interest in using your clinical experience to develop your career in clinical data.
• 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.

Benefits

• Competitive base salary and performance related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Benefits may vary depending on role and location.

Company Description

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Inclusion and Accessibility: ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.