Senior Study Start-Up Specialist

Job Summary

To support the delivery of study start-up and submissions, the full-time Senior Study Start-Up Specialist will manage site selection, ensure compliance with ICH/GCP and local regulations, and drive efficient document management and submission processes in a remote work environment.

Key responsibilities

• Oversee site start-up activities, ensuring timely activation and completion of tasks
• Manage document preparation and submission to central IRB, ensuring compliance and timely reviews
• Contribute to the continuous improvement of study start-up infrastructure and local workflows

Required qualifications

• Bachelor's degree or higher in a scientific or healthcare discipline preferred
• Minimum of 3 years of progressive experience in clinical research and operations
• Familiarity with ICH/GCP and relevant country regulations
• Experience in document management and negotiation within clinical settings
• Proven ability to drive site activations and manage timelines effectively