Study Start-Up Specialist

Job Summary

Assuming leadership during the study start-up process, the full-time Study Start-Up Specialist will coordinate site activations, manage regulatory deliverables, and serve as the primary contact for sponsors and internal stakeholders, ensuring compliance with protocols and regulations.

Key responsibilities

• Lead the development of start-up strategies and manage regulatory deliverables to meet project targets
• Act as the main point of contact for all project-specific Study Start-Up activities and provide regulatory strategic input
• Collect, review, and track essential documents for efficient site initiation and activation while ensuring compliance and completeness

Required qualifications

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent experience
• Minimum of 5 years in the pharmaceutical or CRO industry
• Proven ability to manage multi-country projects during start-up phases
• Outstanding knowledge of ICH GCP across all areas
• Excellent organizational and management skills with strong planning and problem-solving abilities