Jobs

    Senior Manager Clinical Data Management - California, United States - Autoimmune Biotech

    Autoimmune Biotech
    Autoimmune Biotech California, United States

    2 weeks ago

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    Description

    Role Overview:

    As part of the Data Management team, the selected candidate will lead a study within early-phase clinical trials. Operating within an established DM setting, the ideal individual will have the opportunity to take charge from the beginning, manage the study independently, and play a pivotal role in advancing the company's project pipeline.

    Main Duties:

    • Oversee data management tasks throughout the study lifecycle
    • Act as the internal Data Management subject matter expert, collaborating with team members to ensure project milestones are met
    • Engage directly with external vendors and CRO partners
    • Contribute to enhancing operational processes

    Requirements:

    • Preferably hold a Bachelor's degree in a STEM field
    • Minimum of 7 years of relevant industry experience
    • Experience in autoimmune disorders is desirable
    • Proficiency in various data management tools and standards
    • Familiarity with CDISC guidelines
    • Proven track record in regulatory submissions
    • Capable of independent work and thrive in a dynamic biotech setting

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