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