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    Manager, Clinical Data Management - Boston, United States - Bayside Solutions

    Bayside Solutions
    Bayside Solutions Boston, United States

    1 week ago

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    Description

    Manager, Clinical Data Management

    Direct Hire Full-Time Role

    Salary Range: $154,000 - $175,000 per year

    Location: Boston, MA - Hybrid or Remote

    Duties and Responsibilities:

    • Oversee a team of Clinical Data Managers.
    • Manage each project assigned to the team.
    • Perform quality control for each deliverable before sending to internal or external clients.
    • Prepare and present individual performance reviews.
    • Mentor staff and suggest and implement solutions for complex issues.
    • Assist staff with interactions with sponsors and managing vendors.
    • Keep supervisors 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 and study-specific training for the CDM and study teams.
    • Provide input from the data management perspective regarding the design of clinical trial protocols.
    • 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.
    • Participate in the coding of medical terms.
    • Define and perform SAE reconciliation processes.
    • Work with DM leads and database programmers to design (e)CRFs and edit checks in the 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.
    • Prepare training materials and user guides for EDC data collection tools and 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 and identify project scope changes when necessary.
    • Present at sales and marketing meetings for prospective clients.
    • Provide strategic input to the department and company goals.
    • Lead key departmental goals and initiatives.

    Requirements and Qualifications:

    • 10+ years of experience in Clinical Data Management
    • Minimum of 2 years of supervisory experience is required
    • BS in a scientific or health-related field
    • Knowledge of GCPs and regulatory agency guidelines
    • Familiarity with medical terminology
    • 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

    Desired Skills and Experience

    Clinical Data Management, GCPs, regulatory, Medidata RAVE

    Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at

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