Senior Study Start-Up Specialist

Job Summary

A company is looking for a Senior Study Start-Up Specialist.

Key Responsibilities

• Independently identify and resolve site-related issues and risks during the start-up process
• Manage the preparation and submission of regulatory documentation and ensure compliance with local and international requirements
• Collect and maintain regulatory and ethics approvals, and manage essential documents for clinical trials

Required Qualifications, Training, and Education

• Bachelor's Degree or equivalent combination of education, training, and experience
• Pharmaceutical or related industry experience, including regulatory and study start-up experience
• Excellent knowledge of GCP, regulations, and Standard Operating Procedures
• Ability to mentor and lead junior staff
• Demonstrated ability to work independently and collaboratively in a dynamic environment