Manager, Data Management
4 weeks ago
Manager, Data Management
RESPONSIBILITIES
• Manage and supervise a team of Clinical Data Managers (CDMs)
- Oversee each project assigned to the team
- QC each deliverable prior to sending to internal or external clients
- Prepare and present individual performance reviews
- Provide mentorship to DM staff and suggest/implement solutions for complex issues
- Assist staff with interactions with sponsors and managing vendors
- Keep supervisor updated on study progress and staff management through routine meetings
- Maintain a positive, progressive, and proactive management style and communication
• Develop and update data management SOPs and training manuals
• Conduct data management training as well as study specific training for the CDM and study teams
• Provide input from the data management perspective regarding the design of clinical trial protocols
• Oversee, develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures
- Oversee and participate in the process of data review and query generation procedures
- Oversee and participate in the coding of medical terms
- Oversee/define/perform SAE reconciliation processes
• Work with DM leads and DB programmers to design (e)CRFs and edit checks in EDC system
• Ensure proper completion of UAT of EDC system and modules
• Oversee DM lead to ensure efficiency and quality of electronic data receipt, integration, and reconciliation
EDUCATION
• Minimum BS in a scientific or health related field or equivalent
EXPERIENCE
• Minimum of 10 years of experience in Clinical Data Management
• A minimum of 2 years supervisory experience is required
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