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  • Clinical Process Compliance Manager I - North Chicago - AbbVie

    AbbVie
    AbbVie North Chicago

    1 week ago

    Default job background
    Full time Healthcare
    Description

    Job Title: Compliance Manager, Clinical Process Compliance

    About AbbVie

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

    Job Description

    The Compliance Manager, Clinical Process Compliance will be accountable for the interpretation and application of GCP compliance and quality principles as they relate to clinical trial execution.

    This role will facilitate impact assessments of regulatory intelligence working with business partners to translate regulations and requirements into execution of high-quality clinical trial conduct.

    Main Responsibilities:

    • Act as Primary Point of Contact for all GCP compliance-related questions and issues, leading the clinical trial issue escalation process to mitigate serious issues cross-functionally across R&D.
    • Manage capture and closure of issues, risk assessments, potential non-conformities and non-conformities, and effectivity checks.
    • Provide GCP compliance support for site and sponsor inspections, and process and system audits.
    • Support Clinical Trial Business Continuity (BCT) efforts across R&D during times of crisis.

    This role will require excellent collaboration, communication, and working in a matrixed environment.

    Qualifications:

    • Bachelor's degree (or ex-US equivalent) is required; advanced degree preferred.
    • 6+ years of pharmaceutical, healthcare, or clinical research related experience.
    • Demonstrates exceptional analytical and critical thinking skills, consistently employing a logical and systematic approach to problem-solving and decision-making.
    • Demonstrates a comprehensive understanding of the organizational vision and mission, and its direct relevance to the Clinical Process Compliance service model.
    • Demonstrates a solid understanding and proficiency with AbbVie's Quality Manual principles, standard business procedures, and GCP-related regulations.
    • Demonstrates good communication skills in effectively navigating complex and sensitive situations through tactful and strategic communication with cross-functional partners.

    Company Information:

    AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.

    US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

    US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html


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