Global Study Associate

The Global Study Associate assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.

Your responsibilities include:

• 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.

Your qualifications

• 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

Benefits of Working in ICON:revious administrative experience preferably in the medical/ life science field

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

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, 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.