Senior Clinical Data Manager

Job Summary

Leading data management projects in a fully remote capacity, 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 mentoring new team members.

Key responsibilities

• Oversee all aspects of data management, including study-specific issues, data validation, and database lock processes
• Interact independently with clients and data management suppliers to coordinate project facets and negotiate solutions
• Develop and maintain data management documentation and participate in protocol reviews to ensure successful data capture

Required qualifications

• Bachelor's or Master's Degree in a scientific or healthcare field preferred
• 5+ years of experience in the data management field, including at least 1 year in a leadership role
• Extensive knowledge of EDC systems, paper CRF study systems, and hybrid CDM systems
• Strong understanding of Clinical Operations SOPs and Working Practices
• Experience in preparing study tracking and metric reports for project teams