BAS-临床生物分析项目管理(J24695)

Key accountabilities主要职责

1. 01

   Run the clinical bioanalysis project according to the existing SOP.按照现有的SOP运行临床生物分析项目。

2. 02

   Follow SOPs in accordance with GCP/GLP/GCLP regulations.按照 GCP/GLP/GCLP 规定遵守相关 SOP。

3. 03

   Review and input of manuals for clinical trial projects. 审核及补充临床试验项目手册。

4. 04

   Coordinate the communication between the project team and customers, and respond to customer questions in a timely manner. 协调项目组与客户的沟通，及时回复客户问题

5. 05

   Maintain project-related documents and records. 维护项目相关文件和记录。

6. 06

   Monitor the progress of clinical trial projects, conduct risk management and control of the project as a whole, and proactively predict possible problems in the project; 监控临床试验进展，对项目整体进行风险管控，主动预测项目中可能发生的问题;

7. 07

   Coordinate the transfer, testing and reporting of samples. 协调样品的转移、测试和报告。

8. 08

   Prepare project phase/summary report or PPT. 准备项目阶段/总结报告或PPT。

9. 09

   Host and coordinate project kick-off and progress update meeting主持并协调项目启动会及项目进展更新会议。

10. 10

    Assist internal and external audit. 协助内外部审计。

11. 11

    Other tasks arranged by the supervisor. 主管安排的其他工作

1. 01

   Must have earned a bachelor's degree or above in a pharmacology, chemical, physical, biological biotechnical from an accredited institution. 必须获得认可机构的药理学、化学、物理、生物技术或临床检验或医学技术学士或以上学位。

2. 02

   Strong skills, both written and verbal, outstanding interpersonal skill are essential job requirement. Strong English written skill is a must, and verbal skill is a bonus.较强的书面和口头表达能力，较强的人际交往能力及英语读写能力是工作的基本要求。必须有较强的书面英语能力，口语能力是加分项。

3. 03

   Prefer experience with GLP facility, and/or experience with large or small molecule analysis (ADA, Nab, FACS, LC-MS, etc.) project.有GLP环境工作经验及大、小分子（ADA、Nab、流式、LC-MS等）分析或项目经验者优先。

4. 04

   Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives. 必须能够公开分享信息并以团队为导向的方式工作，以实现绩效目标

5. 05

   Proactive, strong sense of responsibility, Good team work spirit and communication skills. 积极主动，责任心强，良好的团队合作精神和沟通能力

6. 06

   Familiar with computer software for Office, PowerPoint, excel, etc. 熟悉Office、PowerPoint Excel等计算机软件。