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    Director Clinical Research - Princeton, United States - System One

    System One
    System One Princeton, United States

    1 week ago

    System One background
    Description

    Title:
    Director of Clinical Research


    Location:
    Must be local Princeton, NJ


    Type:
    Perm


    Start Date:

    ASAP
    Leading Pharmaceutical Company located in NJ is hiring a Director of Clinical Research w/ 10+ years industry experience. If you want to be a part of this groundbreaking work, please apply


    • Prefer a Rare Disease background but not required
    • Must have a MS or above
    • 5yrs of people management - will oversee 3-5 people

    Responsible for:

    • Supervise the members to work for appropriate actions in the department and with other departments or organizations.
    • Manage, oversee, and mentor subordinates, including controlling staff's workload.
    • Collaborate with other department heads and the Head of Clinical Development to enhance and maintain productivity in this group.
    • Research all available scientific information, interview external experts, organize appropriate advisory boards, and leverage the results of these activities, in order to provide scientific information on the Clinical Development Plan (CDP).
    • Provide all necessary leadership and guidance to keep the quality of clinical study-related documents (clinical study protocol (PRT), investigator's brochure (IB), clinical study report (CSR), medical monitoring plan (MMP), safety management plan (SMP), informed consent form (ICF), clinical study data listing/table and regulatory agency/IRB submission document); oversee, write and/or review clinical study-related documents listed above.
    • Collaborate/manage internal and external team members and investigators to review, interpret, and summarize clinical study data and results for finalizing the clinical study topline reports.

    Minimum Experience Requirements:

    • Minimum 5 years of experience as a manager
    • Minimum 10 years of experience in planning/developing, and managing clinical studies within the pharmaceutical industry.
    • Minimum 5 years of experience in supervising the development of clinical study-related documents (e.g., PRT, IB, CSR, MMP, SMP, and regulatory documents)
    • Strong and diverse scientific expertise and/or strong medical background in disease/therapeutic area or clinical safety assessment
    • Knowledge of clinical development-related regulations such as GCPs, ICH guidelines, and requirements for the successful conduct of clinical studies
    • Basic working knowledge of clinical databases, statistics, and pharmacokinetics
    • Attention to detail and ability to process and prioritize complex information and multiple tasks and ability as a hands-off style manager.
    • Ability to collaborate others and work effectively and together.
    • Working knowledge of MS Excel, Word and PowerPoint and related medical writing software


    System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America.

    We help clients get work done more efficiently and economically, without compromising quality.

    System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

    System One is an Equal Opportunity Employer.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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