Study Start-Up Manager State Licensed

Job Summary

A company is looking for a Manager, Study Start Up - Remote in the United States.

Key Responsibilities:

• Supports country SSU strategy and collaborates with SSO Country / Cluster Head Portfolio and global study team to ensure SSU timelines and deliverables are met
• Accountable for timely start-up activities, including preparation of IRB/IEC submission packages, engaging Regulatory Affairs/CTA Hub, and coordinating response to deficiency letters
• Leads site selection, oversees local vendor selection and performance, and ensures sites are prepared for Green Light

Qualifications:

• Bachelor's degree
• Minimum 5 years' experience in clinical operations with project management and/or monitoring clinical trials
• Thorough understanding of international standards (GCP/ICH), health authorities (FDA/EMA), and local regulations
• Strong project management capabilities and problem-solving skills
• Strong interpersonal, negotiation, and conflict resolution skills