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Open nowPosted 208 days ago

临床质量经理

evopointbio/73901724 open roles

Where
Shanghai, Chinese Mainland
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Your applicationOpen now临床质量经理evopointbio/739017 · Shanghai, Chinese Mainland

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: posted 208 days ago

The posting

1.组织团队撰写、审核、发布、培训临床研究标准操作规程（SOPs）；收集意见对SOP进行定期更新和培训； 2.维护和更新与质量相关的内部管理体系和制度； 3.审计临床供应商，保证符合项目质量需求； 4.对临床中心进行稽查，及时发现临床试验中存在的质量问题并监督运营团队进行整改； 5.参与运营团队对药政官方核查工作； 6.根据临床部质量情况和员工培训需求，制订、组织、落实临床部年度和月度培训计划； 7.根据部临床部质量情况及员工素质需求，协助临床部负责人制订培训计划，并检查计划实施情况，总体培训情况和各部门培训检查情况进行总结，对培训效果做出客观评估，提出培训新方案； 8.拓展培训渠道和培训资源，积累培训经验和资料，开发培训课题，编制培训教材，编写培训教案； 9.负责做好员工培训各课目考核与验收工作，做好培训考核和培训评估的管理工作。

1.大学本科及以上学历、临床医学相关专业优先； 2.有2年以上临床试验稽查员工作经验或5年以上临床研究相关工作经验有项目管理经验者优先； 3.熟悉临床试验操作流程； 4.逻辑性强，细致有耐心，善于发现问题，良好的沟通能力及持续学习能力，具备较强的计划能力及执行力；富有责任感，能适应频繁出差； 5.熟练使用Office办公软件，能独立完成稽查报告及相关培训PPT，并完成相关培训； 6.熟悉 ICH GCP、中国GCP、药品注册管理法规等相关临床试验法律法规要求；熟悉药监管方视察（有项目核查经验）、核查工作流程和要点； 7.沟通能力强，能有效与研究者、与部门运营团队协调，发现和解决质量问题；执行力强，能保证SOP和其它质量管理制度有效执行； 8.具有良好的英语沟通能力，有国际多中心临床研究经验者优先。

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