[Hiring] Global Study Associate @ICON plc

Role Description

As a Clinical Trial Associate at ICON, you will assist with the design and analysis of clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders.

• Collect, review, and track study documents.
• Help set up, maintain, close, and archive the Trial Master File (TMF), including regular quality checks.
• Support the creation and management of study documents, ensuring they follow templates and are ready for regulatory publishing.
• Keep information up to date in tracking systems and communication tools, and assist team members in using these systems.
• Coordinate and track study materials and equipment. Assist with tracking and reconciling invoices.
• Provide study metrics and reports for audits and regulatory inspections.
• Organize and help prepare meetings (study team, monitor, investigator, advisory boards).
• Communicate with internal and external team members, vendors, and investigators.
• Prepare and share study-related correspondence and materials for meetings, newsletters, and websites.

Qualifications

• Bachelor’s degree, ideally Honours or Masters in relevant field.
• Good understanding of drug development, specifically oncology, ideally hematology studies, from start-up to close-out.
• At least 3 years of experience supporting multiple clinical studies operationally on a global level.
• Knowledge of ICH-GCP principles.
• Experience supporting regulatory submissions.
• Excellent written and verbal communication skills.
• Experience with some CTM tasks.
• Advanced System and IT skills with the following: AI, eTMF, Excel, Veeva Vault, CTMS, Medidata, IMPACT, Control Room, CLIN vault.
• External vendor experience.
• Proven career achievements.

Requirements

• Seeking candidates wanting to grow and develop into Global Study Management eventually.

Benefits

• 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.