QA
煌途（北京）科技有限公司
- 公司规模：150-500人
- 公司性质：合资
- 公司行业：制药/生物工程
职位信息
- 发布日期：2019-11-09
- 工作地点：北京-大兴区
- 招聘人数：1人
- 工作经验：2年经验
- 学历要求：本科
- 职位月薪：0.8-1万/月
- 职位类别：药品生产/质量管理
职位描述
1、负责组织、制定、更新临床试验质量管理体系中的相关SOP和流程文件;
2、制定项目稽查计划并组织实施，包括对临床试验文件、临床试验用物料、试验现场、外部供应商及合作方的稽查，提供稽查报告和整改意见，并督促整改实施;
3、稽查工作完成后负责定期组织稽查问题分享会;
4、制定针对临床运营团队的相关培训计划。
任职要求：
1、本科及以上学历，临床医学或药学专业;
2、2年及以上临床稽查工作经验，其中项目管理经验1年以上，有多中心临床试验监查或稽查经验优先;
3、熟悉GCP、 ICH GCP相关法律法规，以及FDA/EMEA/CFDA 临床研究质量管理的相关指南;
4、逻辑性强，细致有耐心，善于发现问题，责任心强，能适应出差;5、较强的沟通能力，能准确清晰传递信息和告知稽查结果;
职能类别：药品生产/质量管理
公司介绍
Beijing Health Tech Medical Group (HT-Med) was founded since 2004. We are a comprehensive medical Operation and development organization .Assemble excellent talents of medicine, pharmacy, data management and statistical fields, offering professional services to support biotech and pharmaceutical companies at every stage of product lifecycle .
We provide Medical translation, Data Management, Statistical Analysis, Medical Writing, Regulatory Affairs, Project Evaluation and Management, Independent Audit, Training, CRA/CRC/DM dispatch. Since we established, we were developing new drugs with Chinese Academy of Medical Sciences, Peking University Health Science Center, The General Hospital of the PLA, Military Medical Sciences, etc. Has cooperated with over 90% clinical trial sites (hospital) approved by SFDA.
We developed independently EDC+CTMS by ourselves, obtained 3 patents and 2 brands. Basing on excellent IT capability, we develop Products Data Center for our clients, and created role exchange pattern between CRA and CRC, improved speed&quality of Clinical Study by the model of EDC+CRC, especially in PMS. We have been became the vendor of lots of global company (AZ, GSK, BI, Abbott, Roch, Mundipharma, QPS etc.) and some official Institution (Chinese Academy of Medical Sciences, Peking university, The general hospital of Chinese PLA, Sanming hospital, Zhejiang oncology hospital, Academy of Military Medical Sciences of the Chinese PLA etc.).
We are familiar with China SFDA policy and CDE mentality, possessing mass of expert resource and marketing support. we could cover 90% Chinese certificated clinical research hospital by lots of home-based employee in 18 cities.
公司邮箱：yanmei.wang@ht-med.com
公司网址：http://www.ht-med.com
We provide Medical translation, Data Management, Statistical Analysis, Medical Writing, Regulatory Affairs, Project Evaluation and Management, Independent Audit, Training, CRA/CRC/DM dispatch. Since we established, we were developing new drugs with Chinese Academy of Medical Sciences, Peking University Health Science Center, The General Hospital of the PLA, Military Medical Sciences, etc. Has cooperated with over 90% clinical trial sites (hospital) approved by SFDA.
We developed independently EDC+CTMS by ourselves, obtained 3 patents and 2 brands. Basing on excellent IT capability, we develop Products Data Center for our clients, and created role exchange pattern between CRA and CRC, improved speed&quality of Clinical Study by the model of EDC+CRC, especially in PMS. We have been became the vendor of lots of global company (AZ, GSK, BI, Abbott, Roch, Mundipharma, QPS etc.) and some official Institution (Chinese Academy of Medical Sciences, Peking university, The general hospital of Chinese PLA, Sanming hospital, Zhejiang oncology hospital, Academy of Military Medical Sciences of the Chinese PLA etc.).
We are familiar with China SFDA policy and CDE mentality, possessing mass of expert resource and marketing support. we could cover 90% Chinese certificated clinical research hospital by lots of home-based employee in 18 cities.
公司邮箱：yanmei.wang@ht-med.com
公司网址：http://www.ht-med.com
联系方式
- 公司网站：http://www.ht-med.com1SOPCRA2CRAsPMTMF3PM412CET-6,3GCP4
- Email：yanmei.wang@ht-med.com
- 公司地址：地址：span上海浦东新区张江高科技园区亮景路199号