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Central Review Coordinator
Central Review Coordinator at ICON Strategic Solutions, working in a sponsor‑dedicated model supported by ICON's global expertise. As the world's largest FSP organisation with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
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.
Responsibilities include:
- Create and maintain Study Trackers.
- Monitor screening deadlines; follow up with sites on data entry and other vendor data entry and elevate any visits that are not released for CR review or where queries are not being addressed within the timelines.
- Review and determine that 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.
- Perform 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.
- Participate 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.
- 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.
What ICON can offer you:
- Competitive salary.
- Competitive benefits including: various annual leave entitlements, health insurance offerings, competitive retirement planning offerings, Global Employee Assistance Programme, LifeWorks, life assurance, flexible country‑specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes and health assessments.
- Opportunities for professional development and online courses.
- A dynamic, supportive and collaborative remote team environment.
- Generous paid time off and employee wellness initiatives.
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