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    Lead Clinical Trial Associate - Boise, United States - Idaho State Job Bank

    Idaho State Job Bank
    Idaho State Job Bank Boise, United States

    3 weeks ago

    Idaho State Job Bank background
    Description


    Lead Clinical Trial Associate (Remote) at Takeda Pharmaceuticals in Boise, Idaho, United States Job Description By clicking the 'Apply' button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use .

    I further attest that all information I submit in my employment application is true to the best of my knowledge.


    Job Description OBJECTIVES/ PURPOSE :

    The remote-based Lead Clinical Trial Associate (CTA) will independently perform tasks related to supporting operational strategy, planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.

    + Provide support for critical day-to-day clinical study activities, in accordance with establishedprotocols under the general supervision of the CTA Manager.

    + Provideoversight of deliverables and milestones and/or lead CTA team duringregulatoryinspections and/or develop strategies for regulatoryinspections.

    + Collaborate with Clinical Operations Manager, study teams, and Clinical ResearchOrganizations (CROs) to support clinical study activities asdefined by the clinical trial operating model.

    + Provide leadership to the CTA team and study teams for more complex studies.

    + Performdepartmental tasks asneeded, includingactingas a subjectmatterexpert or lead initiatives and/or processes; make presentations to Clinical Operations; act asmentor to junior CTA team members.

    + Performdevelopmental tasks as appropriate with oversight of CTA Manager.


    SCOPE :

    Leadership/ People:
    No


    of direct reports:
    0 No


    of indirect reports:

    4 Geographic Scope :
    Global:

    Yes Regional:

    Yes Countries:
    Selected countries will be study-specific


    A CCOUNTABILITIES :

    For assigned complex, accelerated, and/or business critical studies, provide support to focus on study start-up and site initiation activities, including but not limited to: + May support more complexprograms and studies to define and execute best clinical trial support strategies.

    + Review and/or approval of study documentation, includingessentialdocumentpackets, study plans, informedconsentforms, etc. + Supportingoversight of risk-based monitoring. + Attendance of key team meetings asrequired; may make presentations (e.g. data, resourcing, initiatives, etc.). + May make presentations to senior leadership of therapeuticareas and/or R&D functionalareas. + Supportingregulatoryinspectionreadiness (e.g. preparation of materials and/or part To view full details and how to apply, please login or create a Job Seeker account
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