Clinical Trial Manager

This is a fully remote position, open to applicants in Australia.

📋 Description

• Operate within a sponsor-dedicated framework enhanced by ICON’s global expertise.

• Oversee study planning, study start-up processes, and activation deliverables for designated projects.

• Ensure adherence to ICON protocols, GCP/ICH standards, and relevant regulatory guidelines.

• Direct all study start-up actions in partnership with the Feasibility Manager, Site Partnership Manager, and the global study team.

• Serve as the primary backup and deputy for the country manager in satellite locations.

• Manage multiple priorities while fostering team development.

• Coordinate start-up tasks from country allocation to Green Light/site initiation readiness.

• Collaborate with local IRBs/IECs and Health Authorities.

• Prepare and finalize local submission packages for IRB/IEC, CTA Hub, and Health Authorities.

⛳️ Requirements

• Bachelor’s degree in a relevant discipline.

• Over 7 years of experience within CROs or pharmaceutical companies.

• Develop SSU strategy in close collaboration with the Study Start-Up Team.

• Ensure SSU timelines and deliverables align with country commitments.

• Execute timely start-up activities from country allocation to Green Light (ready to initiate site milestone) for assigned projects.

• Maintain close collaboration with local IRBs/IECs and Health Authorities, as necessary.

• Conduct and complete study start-up activities on schedule, including the preparation of IRB/IEC submission packages, review of Informed Consent Forms, and liaising with Regulatory Affairs/CTA Hub for Health Authority submissions, as needed.

• Prepare and finalize local submission packages for IRB/IEC, CTA Hub, and Health Authorities as required.

• Legal eligibility to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.