长沙招聘

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. 举报 分享

    诺思格（北京）医药科技股份有限公司是国内专业领先，规模较大的临床研究合同组织（CRO）之一，总部设在北京，办事处设在上海、长沙、广州、武汉、成都、西安、哈尔滨、南京、沈阳、天津、长春、杭州、合肥等省会城市；在国内覆盖60余个城市，在亚洲覆盖6个国家与地区，已与200余家机构，450余家医院及600多个科室合作，目前已为260多位国内外客户提供国际标准的临床研究外包服务。业务涵盖新药评估与咨询、注册事务、临床试验实施、数据管理和统计分析、医学事务及培训等全方位服务。

“服务医药 服务健康”，详情请登录公司主页： *****************

接收简历邮箱：hr@rg-pharma.com（邮件主题：城市+岗位名称+本人姓名）

【子公司】苏州海科医药技术有限公司为诺思格（北京）医药科技股份有限公司的子公司，子公司成立于2015年01月14日，地址位于苏州工业园区裕新路108号4楼，经营范围包括生物技术开发、生物检测技术服务、会务服务，详情请登录公司主页：*******************************/

【子公司】南京艾科曼信息技术有限公司，专攻于临床研究领域中的数据管理和统计分析环节，全面移植美国CRO的质量标准及管理体系，一步到位与国际CRO行业接轨。同时，服务质量获得欧美主要药厂的认证。自成立以来已完成300余项临床项目，其中部分已经获得美国FDA及欧洲EMEA通过。率先使用国际标准数据管理系统，所有高管均有在美国相关行业从业10年以上经验。总部位于北京，在上海、南京、成都、武汉、合肥等省会设有办公室。