- Execute DM activities and deliverables in compliance with ICH/GCP guidelines and SOPs.
- Develop and approve DM documents such as Data Management Plans and Data Review Plans.
- Design and develop Electronic Data Capture (EDC) systems and coordinate their integrations.
- Develop and maintain standard Case Report Form library.
- Provide subject matter expertise for clinical trial documents including protocols and Statistical Analysis Plans.
- Identify, mitigate, and manage risks related to data management issues.
- Develop and implement DM SOPs in partnership with Clinical Operations and Quality Assurance.
- Manage DM external service providers (ESPs).
- Represent DM in interactions with regulatory authorities.
- Lead, train, and mentor DM personnel.
Data management