负责监管临床开发，临床运营，临床用药物，临床服务供应商及药物警戒。

Responsible for oversight clinical development, clinical operation, clinical innovational medicine product, clinical vendors and pharmacovigilance.

1.   按照GCP等相关要求，负责建立和优化临床试验质量管理体系，以达到FDA、EMA、NMPA等监管部门的法规要求；

In accordance with GCP and other relevant requirements, responsible for establishing and optimizing the clinical trial quality management system to meet the regulatory requirements of FDA, EMA, NMPA and other regulatory authorities;

2.   负责组织、制定、更新临床试验质量管理体系，及相关SOP和管理文件；

Responsible for organizing, developing and updating clinical trial quality management system and related SOP, management documents.;

3.   持续跟踪全球临床试验质量相关的主要政策法规更新，确保临床试验的质量要求符合政策法规；

Keep track of the updates of major global policies and regulations related to clinical trial quality to ensure that the quality requirements of clinical trials are in line with policies and regulations;

4.   制定稽查计划并组织实施，完成内外部的质量稽查工作。负责安排临床试验相关的外部第三方稽查和组织完成监管部门的视察；

Formulated and implemented the audit plan and completed the internal and external quality audit. Responsible for arranging clinical trial-related external third-party audits and organizing the completion of inspections by regulatory authorities;

5.   领导各业务部门接受各国药监当局的临床试验现场核查；

Leading related functions to receiving global HA on clinical study sites inspection.

6.   支持、协调临床研究团队质量相关的培训工作，包括但不仅限于临床运营，临床开发，药物警戒，临床用药供应，信息技术部，等；

Support and coordinate training related to the quality of clinical research team, including but not limited for Clinical Operation, Clinical Development, PV, IMP supply, IT, etc.;

7.   制定非临床研究机构的稽查计划并组织实施；

Formulated and implemented the audit plan on non-clinical Lab;

8.   其它相关工作。

Other assigned related work.

1.医药相关专业本科及以上学历;

Bachelor degree or above in medicine related major;

2.10年以上临床试验相关岗位工作经验，其中5年以上临床QA和/或稽查相关工作经验；More than 10 years working experience in clinical trials, including more than 5 years working experience in clinical QA and/or audit;

3.熟练掌握国内外临床试验相关的政策法规，例如ICH-GCP以及FDA、NMPA要求的其它相关法规；

Proficient in domestic and foreign policies and regulations related to clinical trials, such as ICH-GCP and other relevant regulations required by FDA and NMPA;

4.具有搭建临床试验质量管理体系的能力，主导和/或参与过临床试验质量管理体系的建立，包括制定SOP等质量相关管理文件;

Ability to establish clinical trial quality management system, leading and/or participating in the establishment of clinical trial quality management system, including the formulation of quality related management documents such as Sops;

5.有稽查工作的经验和接受过监管部门的核查经验，以接受NMPA, EMA 及FDA等国外监管部门核查经验的优先；

Experience in audit work and inspection experience by regulatory authorities, and inspection experience by foreign regulatory authorities such as NMPA, EMA and FDA is preferred;

6.较强的组织协调管理能力，良好的执行力和沟通技巧；

Strong organization, coordination and management ability, good execution and communication skills;

7.具有优秀的英语沟通能力，能够熟练与国外药政管理部门，合作伙伴及供应商进行会议、邮件等沟通交流。

Excellent English communication skills, able to skillfully communicate with foreign pharmaceutical administration departments, partners and suppliers in meetings and emails.

附加任职要求：

1.最好有跨国企业的2-3年工作经验；

2-3 years working experience in MNC is preferred.