Global Study Associate

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. 

What you will be doing: 

• Collect, review and track relevant study documents.
• Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF). Coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection readiness.
• Support production of study documents, ensuring template and version compliance and that relevant documents are ready for publishing in the regulatory document management system.
• Set-up, populate and accurately maintain information in tracking systems and communication tools. Support other study team members in the use of these systems.
• Manage and contribute to the coordination and tracking of study materials and equipment.
• Assist in the tracking and reconciliation of invoices.
• Support study team and provide study metrics / reports during the study, audits and regulatory inspections.
• Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, investigator meetings and advisory boards.
• Liaise with internal and external participants and/or vendors. Track approvals and completion of required documents.
• Prepare and distribute study-related correspondence. Contribute to and distribute material for meetings, newsletters and websites.

You are:

• University degree / Bachelor’s degree
• Good understanding of drug development
• Minimum of 1-2 years’ experience of administrative / operational support of clinical studies
• Knowledge of ICH-GCP principles
• Team orientated

Compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level

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 maximise 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 website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits 

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, colour, 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.