Clinical Trial Manager

The SSO Study Start-Up Manager is responsible for study planning, SSU activities, and activation deliverables for assigned projects, ensuring compliance with company processes, GCP/ICH, and regulatory requirements in a standalone country, OPC, or satellite country. They lead all SSU activities in collaboration with the SSO Feasibility Manager, SSO Site Partnership Manager, and the global study team. In satellite countries, they act as the primary backup and deputy of the country manager.

Key Responsibilities:

1. Support country SSU strategy in collaboration with the SSO Study Start-Up Team Lead, SSO Country Head, and SSO Cluster Head.
2. Collaborate with various stakeholders to meet SSU timelines and deliverables.
3. Ensure timely start-up activities from country allocation to Green Light milestone.
4. Coordinate with IRBs/IECs and Health Authorities for submissions and approvals.
5. Prepare and finalize local submission packages for IRB/IEC, CTA Hub, and Health Authorities.
6. Respond promptly to deficiency letters and manage reportable events.
7. Maintain accurate and inspection-ready TMF documents.
8. Adhere to financial, legislative, and regulatory standards.
9. Implement efficient processes aligned with company strategy.
10. Support study feasibility and lead site selection and vendor performance oversight.
11. Oversee local SSU team activities to meet timelines and quality standards.

Minimum Requirements:

• At least 5 years of experience in clinical operations or monitoring clinical trials.
• Ability to lead in a matrix environment without direct reports.
• Understanding of all aspects of clinical drug development, especially trial setup, execution, and monitoring.

ICON offers a diverse and inclusive work environment with competitive benefits, including health insurance, retirement plans, flexible benefits, and support programs. For more information, visit our careers website.

We are committed to equal opportunity and welcome applications from all qualified candidates. If accommodations are needed during the application process, please contact us through the provided link.

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