Direct Biologics

Director

• Successful and timely execution of DM activities and deliverables in compliance with International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines and Standard Operating Procedures (SOPs)
• Develops and/or approves DM documents, including Data Management Plans, Data Transfer Agreements, and Data Review Plans
• Designs and develops Electronic Data Capture (EDC)
• Oversees and coordinates EDC integrations
• Develops and maintains standard Case Report Form library
• Provides subject matter expertise to the development of trial documents, including Protocols, Monitoring Plans, Statistical Analysis Plans, and Clinical Study Reports
• Proactively identifies, mitigates, and manages risk in data management issues
• Develops and implements DM SOPs in partnership with Clinical Operations and Quality Assurance
• Manages DM external service providers (ESPs)
• Represents DM in interactions with regulatory authorities, as needed
• Applies current industry best practices to DM systems and processes
• Leads, trains and mentors DM personnel
• Performs other duties as assigned

Director, Data Management