Study Start Up Specialist/Sr. Study Start Up Specialist

📋 Description

• Coordinate and oversee site activations per contract, protocol and regulatory requirements.
• Lead study start-up activities and serve as main contact for Sponsor and internal teams.
• Ensure regulatory deliverables developed, tracked, and aligned with procedures and templates.
• Prepare and manage regulatory submissions and essential documents for TMF filing.
• Coordinate with sites, CKTs and departments on document processing and site activation.
• Support training, budgets, and proposal development as needed.

🎯 Requirements

• Bachelor’s Degree in Chemistry or Life Sciences, Nursing or equivalent experience
• Minimum 5 years in pharmaceutical/CRO industry
• Experience managing multi-country start-up projects
• Exceptional organization, planning, and problem-solving skills
• Strong English written and verbal communication
• Proficiency in MS Office (Word, Excel, PowerPoint)