Study Start-Up Manager State Licensed

Location: Remote
Compensation: Salary
Staff Reviewed: Mon, Feb 12, 2024
This job expires in: 18 days

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

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