Manager, Data Management
3 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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