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    Community Lead, Temporary - Hamilton, ON, Canada - Allergan

    Allergan
    Allergan Hamilton, ON, Canada

    2 weeks ago

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    Description

    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.

    Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

    AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data.

    This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.

    Oversee the production of all Data Sciences timelines and deliverables for assigned clinical trials and all DSS-related cross-functional meetings with clinical teams, safety teams and physicians
    Oversee all EDC,and IRT vendor contracts for assigned clinical trials
    Supervise all Data Sciences staff (including equivalent CRO staff) for assigned clinical trials
    Co-represent Data and Statistical Sciences at any meetings with FDA and regulatory agencies regarding assigned clinical trials

    Lead clinical study team in the development of key clinical trial systems, study conduct and study close-out as related to Data and Statistical Sciences (DSS) operational activities.

    Create and manage Data Sciences communications plan for all assigned clinical trials. Exercises real, but informal authority over Data Sciences study team members' daily tasks and timelines.
    Manages 4 to 7 clinical trial startups concurrently
    Plan and manage all Data Sciences timelines and deliverables for assigned clinical trials.

    Complete trial-specific Statement of Work (SoW) based on parameters supplied by Master Service Agreement (MSA) for Electronic Data Capture (EDC), electronic Patient Reported Outcomes (ePRO) and Interactive.

    Manage and maintain vendor budgets for assigned clinical trials and process flows and data exchanges with global pharmacovigilance for clinical trial serious adverse events.

    Manage any internal quality assurance audit for assigned clinical trials.

    Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports.

    Anticipates and identifies issues that could affect timelines or quality and develops options and solutions

    Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards.

    Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development. If assigned, participates as the DS study owner in regulatory inspections and internal quality audits
    Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance
    May include indirect supervision of employee as well as supervision of work of contract resources
    Bachelor'sdegree in business, management information systems, computer science, life sciences or equivalent.

    Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience).

    Management of a clinical trial from initiation through to completion in a lead role is preferred
    Demonstrated performance as a functional leader

    We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligible employees.

    This job is eligible to participate in our short-term incentive programs.

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

    It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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