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您当前位置:mobile365>>诺思格(北京)mobile365科技股份有限公司>> 临床质量管理专员(QA/QC)
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    • 诺思格(北京)mobile365科技股份有限公司
    • 所在地区:北京
    • 企业性质:中外合营(合资.合作)
    • 企业规模:500人以上
     临床质量管理专员(QA/QC) (6-23)
    分享到:
    • 工作地点:北京
    • 招聘人数:3人
    • 薪资待遇:面议
    • 工作年限:三年以上
    • 学历要求:本科及以上
    • 性别要求:-
    职位描述:

    CORE JOB TASK
    ·Implement and deliver the agreed upon R&G Yearly Quality Control (QC) plan which includes risk management, to assist Clinical Operations to deliver compliance activities with relevant ICH, GCP, country regulations and guidelines.
    ·Conduct co-monitoring per QC plan, mentor and coach CRA when applicable.
    ·Support Clinical Operations team in preparing for sponsor audits and provide input into the generation of timely and appropriate audit response plans and assisting in preparation and responses for regulatory authority inspections
    ·Provide compliance support by answering questions or providing advice on GCP, SOPs, regulations and guidelines and bring issues to the attention of Clinical Operations Head as appropriate
    ·Participate in R&G and department system/standards improvement activities.
    ·Contribute to the development of and responsible for implementation and delivery of specific initiatives as defined and agreed upon.
    ·Work as the project manager and faculty to conduct instructor-led training to Clinical Operations on GCP, SOPs and related regulations or guidelines.
    ·Review, revise, write and implement, as required, Clinical Operations SOPs.

    MINIMUM REQUIREMENTS
    ·A Bachelor Degree in a medical, health, or science related are, or a nursing degree.
    ·Minimum of 3 years related experience in clinical trial management or related areas including at least 2-year experience in Clinical Operations and 1 year experience in Quality Control or Quality Assurance is preferred.
    ·Good understanding of Phase I – IV clinical trials quality control principles, clinical monitoring procedures, all relevant GCP guidelines and of local and international regulations.
    ·Knowledge of medical terminology and high proficiency in Microsoft Word / Excel / Powerpoint / Outlook
    ·Excellent, interpersonal, communication and organizational skills.
    ·Good team player, self-motivated and attention to details.
    ·Strong customer focused sensitivity towards internal and external customers.
    ·Competent in written and oral English.
    ·Able to travel when required.

    企业联系方式

    • 联系人:HR
    • 联系电话:点击查看
    • 电子邮箱:点击查看
    • 企业地址:北京海淀区车公庄西路 19 号华 通大厦 B 座北塔11 层

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