Green Key Resources

Manager, Data Management

Green Key Resources Cambridge, MA
Green Key Resources

Manager, Data Management

Green Key Resources Cambridge, MA
3 weeks ago
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Responsibilities

  • Manage and supervise a team of Clinical Data Managers (CDMs)
  • 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, Postproduction 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
  • Review queries and trends to ensure data completeness and integrity.
  • Review/prepare training materials and user guides for EDC data collection tools, deliver user training.
  • Participate in client and team meetings as required advising on best practices as appropriate.
  • Provide input to cross-functional study timelines and resource requirements to ensure timely completion of project milestones for complex studies.
  • Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes.
  • Implement technical solutions, new tools, and process improvement strategies.
  • Lead large and complex projects.
  • Identification of project scope changes.
  • Present at sales and marketing meetings for prospective clients.
  • Provide strategic input to the department and company goals.
  • Lead key departmental goals and initiative.

Requirements

  • Minimum BS in a scientific or health related field or equivalent
  • Minimum of 10 years of experience in Clinical Data Management
  • Minimum 2 years supervisory experience is required.
  • Knowledge of GCPs and regulatory agency guidelines
  • Familiarity with medical terminology is required.
  • Skilled in the use of data management software application, Medidata RAVE
  • Excellent organizational and time management skills
  • Strong collaboration and leadership skills
  • Excellent oral and written communication skills
  • Strong interpersonal skills

  • Seniority level

    Director

  • Employment type

    Full-time

  • Job function

    Information Technology

  • Industries

    Staffing and Recruiting

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