Study Start-Up Lead

Job Summary

A company is looking for a Study Start-up Lead to manage and conduct start-up activities in compliance with client procedures and regulations.

Key Responsibilities

• Manage and conduct start-up activities at the country level, ensuring compliance with guidelines and regulations
• Prepare, review, track, and manage site regulatory documentation and performance metrics
• Collaborate with the Local Study Team to achieve study start-up milestones efficiently

Required Qualifications and Education

• Experience in clinical research or related field
• Knowledge of ICH-GCP and relevant regulatory requirements
• Proficiency in managing regulatory submissions and documentation
• Ability to work collaboratively within a team environment
• Familiarity with Clinical Trial Management Systems (CTMS) and electronic Trial Master Files (eTMF)