锦鲤求职岗位描述
岗位职责
1. Be capable of independently conducting project research, literature research and information organization;
能够独立开展项目调研、文献查询和信息整理;
2. Lead IB / protocol / CSR/ registration materials (e.g., M2.5 & M2.7) writing and translating and SOP maintenance, ensure full GxP and Related Guidance compliance in materials;
主导撰写和翻译研究者手册/方案/临床试验报告/注册资料（如M2.5&M2.7）/完善SOP，并保证符合GxP和相关指导原则的要求；
3. Answer and handle medical issues during the project execution process, interpret and analyze the data, and organize the results;
对项目执行过程中的医学问题进行解答和处理，对数据进行解读及分析、结果整理;
4. Participate in some medical monitoring work;
参与部分医学监查工作;
5. Conduct study design independently for supporting business development；
独立开展方案设计支持商务发展；
6. Fully responsible to deliver assigned projects under established timeline;
负责在规定时间内交付安排的项目；
7. Conduct training for new employee and relevant staff;
对新员工和相关人员实施培训
8. Maintain a good communication and interaction with sponsor, clinical center and other relevant unit;与申办方，中心和其他相关部门保持良好的沟通和交流；
9. Maintain a good communication and interaction with line-manager.
与直线领导保持良好的沟通和交流。
岗位要求
Master/Ph.D. degree in clinical medicine / clinical pharmacology or in relevant area.
临床医学/临床药理或相关专业，博士或硕士教育背景。
At least 3 years of work experience in clinical pharmacology depending on the degree, direct CRO/Pharma or other business –related experience, experience of clinical pharmacology studies is highly desirable.
根据学历至少3年临床研究经验，CRO/制药企业或其他相关的业务经验。
Good knowledge of clinical medicine/clinical pharmacology/pharmacokinetics
良好的临床医学/临床药理/药代动力学知识。
Good knowledge and experience (e.g., bioequivalence / phaseⅠ/Ⅱ/Ⅲ study) in protocol design and clinical report compilation。
良好的临床方案设计和报告撰写知识和经验(如生物等效性试验、Ⅰ、Ⅱ、Ⅲ期临床试验)。
Understand current GCP/CLP and related Guidance in CFDA/FDA/EMA/ICH.
了解现行GCP/CLP和其他相关指导原则。
Good in both Chinese and English.
良好的中英语水平。