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    Manager Clinical Data Management - Cambridge, United States - ClinLab Staffing

    ClinLab Staffing
    ClinLab Staffing Cambridge, United States

    1 week ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    MANAGER DATA MANAGEMENT

    Cambridge, MA, US

    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
    • 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

    EDUCATION

    • Minimum BS in a scientific or health related field or equivalent

    EXPERIENCE

    • Minimum of 8-10 years of experience in Clinical Data Management
    • Minimum 2 years supervisory experience is required

    SKILLS

    • 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
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