Country Study Start-Up Specialist

📋 Description

• Drive start-up and maintenance activities for assigned studies/sites.
• Develop country/site activation plans with risk mitigation.
• Coordinate with regulatory/CTS for CA submissions and approvals.
• Manage site activation with contract manager, Site Monitor, and Leads.
• Trigger IP shipments, issue green light letters, and activate sites in IXRS.
• Maintain SSU KPIs and audit readiness; ensure policy compliance.

🎯 Requirements

• Bachelor's degree in health care or science preferred, or equivalent experience.
• 1-2 years in clinical research; 1+ year in study start-up management (region).
• Experience with remote/virtual teams and strong interpersonal skills.
• Working knowledge of ICH/GCP and local regulatory environment.