项目经理
希米科（北京）医药科技有限公司
- 公司规模：少于50人
- 公司性质：外资（非欧美）
- 公司行业：制药/生物工程
职位信息
- 发布日期：2016-11-14
- 工作地点：北京-朝阳区
- 招聘人数：1人
- 工作经验：5-7年经验
- 学历要求：本科
- 语言要求：英语 熟练
- 职位月薪：1-100/月
- 职位类别：项目经理/主管
职位描述
职位描述：
职位描述：
1. 通过规范的监查过程，保证临床试验按国家GCP要求和试验方案进行；
2. 试验用药物和物品的正确保管、发放和使用；
3. 填写相关报告及试验记录，确保数据真实准确、完整无误。
任职要求：
1. 临床医学或医药学相关专业，本科及以上学历；
2. 五年以上CRA工作经验；
3. 熟悉药品注册管理办法、药品临床试验及GCP等相关法规；
4. 英语水平CET-4 或CET-6，具有良好的英文读写及口语能力；
5. 有良好的人际关系和良好的沟通及语言表达能力；
6. 能够适应经常出差。
7.***
RESPONSIBILITIES
1, CRA is responsible for clinical research tasks relating to the sites in charge, conducted in CMIC
such as monitoring, filing and reporting.
2, CRA is responsible to confirm that the assigned study is conducted in line with the relevant
regulatory requirements/procedures, e.g. applied GCP, local regulations/rules, SOP.
3, CRA shall play a role of an intermediate among CMIC, investigator and sponsor.
4, CRA shall report on something like progress of the study, to PM, CPL/Sub-CPL, CR Manager.
REQUIREMENT
1,Must be certified as a CRA in compliance with SOP.
2, Familiar with all the regulatory guidelines and procedures such as ICH/local GCP, SOPs etc.
3,Knowledgeable with the information of study drug such as investigational brochure and with
all requirements of the protocol.
4,Ability to work in a team environment.
5, Clear & professional written & oral communication.
6, Good interpersonal skills
7, Business level English skill for the multi-national project
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职位描述：
1. 通过规范的监查过程，保证临床试验按国家GCP要求和试验方案进行；
2. 试验用药物和物品的正确保管、发放和使用；
3. 填写相关报告及试验记录，确保数据真实准确、完整无误。
任职要求：
1. 临床医学或医药学相关专业，本科及以上学历；
2. 五年以上CRA工作经验；
3. 熟悉药品注册管理办法、药品临床试验及GCP等相关法规；
4. 英语水平CET-4 或CET-6，具有良好的英文读写及口语能力；
5. 有良好的人际关系和良好的沟通及语言表达能力；
6. 能够适应经常出差。
7.***
RESPONSIBILITIES
1, CRA is responsible for clinical research tasks relating to the sites in charge, conducted in CMIC
such as monitoring, filing and reporting.
2, CRA is responsible to confirm that the assigned study is conducted in line with the relevant
regulatory requirements/procedures, e.g. applied GCP, local regulations/rules, SOP.
3, CRA shall play a role of an intermediate among CMIC, investigator and sponsor.
4, CRA shall report on something like progress of the study, to PM, CPL/Sub-CPL, CR Manager.
REQUIREMENT
1,Must be certified as a CRA in compliance with SOP.
2, Familiar with all the regulatory guidelines and procedures such as ICH/local GCP, SOPs etc.
3,Knowledgeable with the information of study drug such as investigational brochure and with
all requirements of the protocol.
4,Ability to work in a team environment.
5, Clear & professional written & oral communication.
6, Good interpersonal skills
7, Business level English skill for the multi-national project
职能类别： 项目经理/主管
公司介绍
CMIC Group was the first company to provide CRO (contract research organization) services in Japan. Relevant laws and rules had not been established when the group was first established. The CRO Study Group (which later became the Japan CRO Association) was formed by Mr. Kazuo Nakamura, the current CEO of CMIC Group, and others to conduct promotion and public relations activities and to negotiate with the authorities for the establishment of CROs in Japan.
Later, when the new Good Clinical Practice (GCP) regulations came into
Later, when the new Good Clinical Practice (GCP) regulations came into