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    Executive Director Clinical Data Management - California, United States - Meet

    Meet
    Meet California, United States

    6 days ago

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    Description

    The Executive Director of Clinical Data Management (CDM) will play a pivotal role in overseeing both the operational and strategic aspects of data management across the organization. This includes ensuring data governance, maintaining data quality, and driving data strategy initiatives. Collaborating closely with CRO partners, this role aims to promote consistency in data collection, reporting, and structure while providing daily support for a dynamic and fast-growing company.

    Key Responsibilities:

    • Strategic Leadership: Provide leadership, oversight, and strategic direction to the CDM function, driving excellence in delivery and ensuring alignment with organizational goals.
    • Operational Oversight: Oversee CRO data management staff, contributing to the development of clinical data management practices within the company.
    • Collaborative Strategy: Collaborate with the clinical development team to develop short-term and long-term strategies for enhancing data management quality and efficiency.
    • Regulatory Compliance: Ensure projects are conducted in compliance with operating procedures, GCP, ICH, FDA regulations, CDISC standards, and submission requirements.
    • Document Review: Review and provide feedback on study documents such as data management plans, study protocols, Statistical Analysis Plans, and Clinical Study Reports.
    • Data Review Activities: Coordinate and lead internal and external clinical data review activities to ensure completeness, accuracy, and consistency in accordance with the data management plan for all studies.
    • SOP Development: Lead the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.
    • Vendor Management: Co-lead vendor and technology evaluation, qualification, and selection, ensuring alignment with Biometrics needs and industry regulations.
    • EDC Oversight: Lead the development and implementation of CRF standards for data collection, ensuring compliance with study protocols and quality standards.
    • Data Transfer Management: Review and approve data transfer plans for external data imported into EDC, and manage reconciliation between EDC and non-EDC databases.
    • Database Lock: Coordinate activities to lock clinical databases, develop timelines, assign tasks, and ensure timely completion of data cleaning activities.
    • Budget Management: Manage and track work orders associated with clinical data management activities to ensure operating costs are achieved within budget.
    • Stakeholder Education: Educate clinical team members on data management processes, workflow, and standards.
    • Relationship Management: Cultivate effective working relationships with colleagues, vendors, and management, solving problems and escalating issues as needed.

    Core Competencies and Requirements:

    • In-depth knowledge of FDA regulations, GCP, GCDMP, CDISC, 21CFR Part 11, and ICH guidelines.
    • Proficiency in EDC systems, SQL, database programming, clinical operations, and quality management.
    • Experience with MedDRA, WHODrug, and other controlled terminology systems.
    • Proven leadership and negotiation skills, with the ability to drive results across a matrix organization.
    • Strong budget management and resource allocation skills.
    • Excellent written and oral communication skills.
    • Ability to work independently in a fast-paced environment.
    • Proficiency in MS Office suite.

    Requirements:

    • Education: BS/MS/PhD in Life Sciences, Statistics, Informatics, Computer Sciences, or related fields.
    • Experience: 14+ years of clinical data management experience in pharmaceutical and/or CROs, preferably with complex and international trials.
    • Travel: 5% – 10%
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