临床质控和培训主管（上海）
Pharmaceutical
Full-time
Shanghai
Posted on 28 May 2025
Posted on 28 May 2025
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Job Function
- Manufacturing & Quality Assurance
Discipline
- Medical Sciences
- Medicine
- Pharmacy
Years of Experience
- 4-6 years
Job Details
Responsibilities
- 搭建临床运营质量控制体系，制定临床运营质量管理计划、内部风险、质量管理计划并监督执行。起草、更新内部临床运营相关SOP。
- 根据项目的优先级和项目阶段，制定和执行年度临床项目质控计划（包括但不限于项目文件质控、中心质控访视，月度质量KPI分析与报告），反馈和改善临床运营流程。
- 向临床运营成员提供GCP/临床运营sop等培训，管理相关培训记录。
- 作为质控负责人，与稽查部（QA）共同应对国家药物监管机构发起的视察、稽查、核查等任务。
Requirements
- 具有5年以上临床研究经验，其中包含1年临床质控管理经验。
- 既往参与撰写、审核过sop、业务流程指南等，可独立组织提供相关培训。
- 具有较强的风险管理和控制能力。
- 具有很强的沟通协调和解决问题能力。
- 具有较强的国际化视野和关键思考力。
About the Company
Overview
Simcere Pharmaceutical Group Limited (2096.HK) is a pharmaceutical company driven by innovative R&D. We are committed to "For patients, for life." across the following core therapeutic areas: oncology, central nervous system, autoimmunity and anti-infection. Furthermore, we are also actively expanding our presence in disease areas with significant clinical needs in the future.
Our industry-leading capabilities and commitment to synergistic innovation have also enabled various strategic collaborations and we are seen as the partner of choice by innovative biopharmaceutical companies, medical institutes, and research teams in China and globally.