Senior Clinical Data Manager

Job Summary

To support a growing clinical research organization, the full-time Senior Clinical Data Manager will oversee the entire data management process from study set-up to close-out, ensuring compliance with GCP/ICH guidelines and FDA regulations while working remotely from Brazil.

Key responsibilities:

• Manage data management processes, including study set-up, data validation, and database lock
• Coordinate directly with clients and data management suppliers to maintain strong relationships and resolve issues
• Develop study documentation and training materials, mentoring new clinical data managers

Required qualifications:

• Bachelor's or Master's Degree in a scientific or healthcare field preferred
• 5+ years of experience in data management, with at least 1 year in a leadership role
• Extensive knowledge of EDC systems and clinical operations SOPs
• Strong understanding of GCP/ICH guidelines and FDA regulations
• Proficiency in developing study documentation and metrics reports