Senior Clinical Data Manager

Job Summary

To support a growing clinical research team, 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 Colombia.

Key responsibilities:

• Manage data management processes, serving as the primary contact for study-specific issues and maintaining strong client relationships
• Oversee data management study documentation and provide training and mentorship to new clinical data managers
• Coordinate interactions with cross-functional teams to ensure timely completion of project timelines and deliverables

Required qualifications:

• Bachelor's or Master's Degree in a scientific or healthcare field preferred, along with relevant industry experience
• 5+ years of experience in the data management field, including at least 1 year of project leadership experience
• Extensive knowledge of EDC systems and clinical operations SOPs
• Strong understanding of drug development processes and data management best practices
• Proficiency in creating training materials and conducting user acceptance testing (UAT) for study-specific systems