Manager, Data Management

3 weeks ago


Boston, United States THOR Companies Full time

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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