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    Clinical Trials Regulatory Manager - Durham, United States - IQVIA, Inc.

    IQVIA, Inc.
    IQVIA, Inc. Durham, United States

    4 weeks ago

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    Description
    Job Description Summary

    Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex

    Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.

    Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements.

    Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications with minimum support of senior staff

    May strategically plan and perform European centralized submissions and facilitate global submissions

    May provide support on regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs)

    Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.


    Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).

    Deliver regulatory training/presentations as required.

    May perform additional tasks as deemed appropriate by Line Manager


    IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.

    We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.

    Learn more at

    We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.


    IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.


    The potential base pay range for this role, when annualized, is $103, $173, The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).

    Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

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