Central Review Coordinator

ICON Strategic Solutions; South Africa; On-site; ZAR 300,000 - 480,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

LifeWorks EAP

Life assurance

Flexible country-specific benefits

Job summary

ICON Strategic Solutions is seeking a Central Review Coordinator to join our sponsor-dedicated model, backed by ICON’s global expertise. The role centers on independent, centralized endpoint data evaluation, grading, and data management for a Big Pharma FSP.

You will lead study trackers, review readiness, assign reviewers, and ensure timely data processing within a collaborative CRO team. Growth in clinical data responsibility is supported by robust processes.

Qualifications

• BSc Life Science degree with solid CRO/pharma industry experience.
• Desire to develop clinical data career using clinical experience.
• Strong communication skills, both written and verbal, in a team environment.
• Experience with data management systems, especially Rave.

Responsibilities

• Create and maintain Study Trackers.
• Monitor screening deadlines and escalate data-entry issues.
• Assess study visits readiness for review using status and reports.
• Assign reviewers and track queries and tasks.
• Download and compile files for patient profiles and post on CRS portal.
• Prepare internal CRS agendas and distribute meeting minutes.
• Update action/decision logs and file documents in eTMF/portal.
• Liaise with Directors, Therapeutic Expertise, team members and Sponsors.
• Review study datasets prior to client transfer when applicable.
• Monitor progress to meet timelines and report risks to the Lead Central Review Manager.
• Participate in database lock activities.
• Serve as CR Coordinator on multiple projects.

Skills

Communication skills

Time management

Attention to detail

Team collaboration

Education

BSc Life Science

Tools

Rave

Microsoft Word

Microsoft Excel

Job description

At ICON Strategic Solutions, you will work 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 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
• 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

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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized 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