Study Start-up Lead

Job Summary

Managing start-up activities at the country level, the full-time Study Start-up Lead will ensure compliance with local and international guidelines, prepare and track regulatory documentation, and collaborate with cross-functional teams to achieve study milestones in a remote setting.

Key responsibilities

• Oversee the collection, preparation, and submission of regulatory documents to authorities during the start-up period
• Maintain and update site performance metrics and essential documents in accordance with ICH-GCP and client SOPs
• Collaborate with the Local Study Team to ensure timely resolution of outstanding actions and effective communication of study milestones

Required qualifications

• Bachelor's Degree, preferably in life sciences
• Minimum of 5 years of experience in a Clinical Research environment with a focus on Start-Up
• Strong project management skills with a deep understanding of regulatory and submission processes
• Proven ability to manage multiple priorities and meet tight deadlines