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  • 11-09 发布
  • 五险一金
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职位描述

职位描述: 职位描述: 1、根据SFDA法规要求,进行临床试验项目的管理和质量控制,包括临床试验基地筛选,伦理报批、启动会组织、PI沟通、现场访视和质量监控等工作。 2、根据项目计划及进度表对所负责的研究中心进行全面的监查联络管理,按时完成临床试验在该中心的启动、执行及结束工作,确保项目按计划实施。 3、核查并确保CRF中数据的合法性、准确性和完整性 。 4、及时沟通项目经理、申办者和研究者,确保临床试验符合GCP和SOP规范,严格按照临床试验方案进行。任职要求: 1、临床医学或药学相关专业毕业 。 2、具有较强沟通能力,计划能力,组织协调能力,优秀的团队合作能力;具有独力工作的能力,但同时又具有很强的集体意识。 3、清晰的书面及口头表达能力,善于进行活跃而积极的沟通。可适应经常出差。 职能类别: 临床数据分析员 关键字: 临床监察

联系方式

恒华大厦

公司信息

诚 聘 英 才 国信医药科技(北京)有限公司是一家活跃在医药咨询及医药研究领域的专业服务提供机构,作为国内领先的CRO公司。国信医药以“专业性、高效性、优质性”的宗旨,为国内外医药企业和新药研究机构提供临床试验研究、研发专业技术和医药信息咨询等相关服务。 国信医药与卫生部、国家食品药品监督管理局、国家中医药管理局等相关部门及检验机构有着长期、良好的合作关系。拥有一批由此领域内的资深专家组成的专业顾问团队,凭借广泛的社会资源、畅通的服务渠道,以及对相关政策法规、申报流程的深入了解,目前和众多企业合作并已为多家企业成功申报。公司致力于为国内外优秀企业提供全方位、专业化的研究咨询服务,主要业务范围包括医药产品临床试验的组织和运作管理,药品、器械、保健品注册及市场准入服务,医药行业市场研究与咨询,为更多的优秀产品进入市场提供一个良好的服务平台。合作客户包括大型跨国制药公司、国内研发型制药企业、相关政府机构以及专业学术团体等。 Beijing Guoxin Ze Ding International Medical Technology Co., Ltd. Beijing Guoxin Ze Ding Technology Co., Ltd. is an international pharmaceutical active in the field of medical consultation and medical research of professional service providers, as a leading CRO company. Guoxin Ze-ting of "professionalism, efficiency, quality," the purpose of domestic and foreign pharmaceutical companies and research institutions, clinical trials, drug research, reporting and registration matters and other related medical information consulting services. Guoxin Ze-ting with the National Ministry of Health, the State Food and Drug Administration, the State Pharmaceutical Administration and other relevant departments and inspection bodies have a long-term good relations of cooperation. This area has a group of senior experts team of professional consultants, with a wide range of social resources, smooth service channels, as well as relevant policies and regulations, in-depth understanding of reporting procedures, as of now, our company has many businesses establish long-term stable cooperative relations and to assist enterprises to declare the successful completion of registration. The company is honesty, with excellent consulting team-based, the emphasis on contract and credit, friendly cooperation and common development of the spirit of commitment to outstanding Chinese and foreign enterprises to provide comprehensive, professional research and consulting services to major lines of business the scope of clinical trials of pharmaceutical products, including the organization and operational management, pharmaceuticals, equipment, health care products registration and market access for services, the pharmaceutical industry market research and consulting with our high value-added brands, high-quality personnel, efficient style and the cautious attitude of the excellent enterprises for more excellent products into the market provide a good service platform. Co-clients include major multinational pharmaceutical companies, domestic well-known pharmaceutical companies, relevant government agencies and professional academic organizations. 有意者可将详细简历发邮件(fengsihan@gxzdpharma.com)至我公司。

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