职位目标 Job Purpose
保证公司药品临床研究的顺利完成，为其他部门提供有关产品的临床医学支持
Ensure the smoothly completion of clinical trial of TSKF product, provide medical support to other Dept
保证临床试验质量和进度
Ensure the quality and time line for the trials
主要工作职责 Key Responsibilities: 1. 参与制定新产品临床研究策略，保证得到公司内部相关部门总监的批准
Participating in making study strategy of new product clinical trial, ensure it get approval from related Dept head.
2. 负责新产品临床研究组织，实施和临床监察的计划制定及项目管理，保证此过程符合国家及Takeda总部GCP(Good Clinical Practice)的要求；
Be responsible for new product clinical project planning and management, including sponsoring, conducting and monitoring, ensure this procedure is in compliance with GCP requirement of SFDA and GSK Central.
3. 审核修改临床研究协调员撰写的临床研究方案，病例表格等研究文件，保证得到区域和总部相关部门的批准；
Review and revise clinical documents like protocol, case report form, etc, ensure it get approval from country medical director and appropriate central medical head.
4. 组织完成临床的各期研究者会议，促进临床研究的如期进行；
Organizing, conducting each phase investigator meeting, promote on time completion of clinical trial.
5. 审核修改临床研究协调员撰写的临床研究总结报告，并符合国家药品注册的要求；
Review, revise clinical study report, ensure it meet the registration requirement of SFDA.
6. 做好与临床基地间的沟通与协调；
Make good communication and associate between Tianjin Takeda and clinical study site.
7. 配合完成公司产品注册相关工作；
Cooperating with other Dept to finish new product registration.
8. 深入了解产品及相关的医学专业背景，为市场部、销售部、培训部提供相关产品的医学支持，包括审核促销资料，审核药品说明书以符合Takeda总部相关要求；
Deep understanding of TSKF product and its background medical knowledge, provide medical support to Marketing, Sales, training Dept, including review and approval of promotion material, reviewing product information to make sure it in accordance with Takeda central requirement.
9. 负责与药政部门协商有关临床研究的技术事宜；
Be responsible for discussing clinical research technical issues with SFDA.
10. 按照国家和Takeda总部的要求，协助安全事务专员，负责我公司药品的临床试验中的不良反应监测和报告；
Assist safety advisor, responsible for Tianjin Takeda product pharmacovigilance to ensure it meet the requirement of SFDA and Takeda central safety Dept, deal with SAE by cooperating with other Dept.
任职条件Qualifications: 大学本科或以上学历，医学专业
Bachelor degree of medical/clinical science or above.
任职经验Working Experience:
5年以上制药行业药品医学临床工作经验，外资药业工作经验为佳。
More than 5 years clinical research experience in Pharmaceutical, foreign capital is preferred.
专业知识/技能Professional Knowledge/Skill :
1. 医学专业知识，尤其是临床药理学和医学统计学
Medical speciality, especially clinical pharmacology and medical statistics.
2. 药品临床研究规范
GCP(Good Clinical(Practice),SOP(Standard(Operating(Procedure)
3. 临床研究协调
Clinical Research Association
4. 计划和项目管理
Project planning and management
5. 国家药政法规
State Pharmaceutical Administration Regulation
6. 市场和销售知识
Marketing and Sales knowledge
7. 熟悉产品知识及相关疾病的知识
Familiar with knowledge of Tianjin Takeda product and related disease.
计算机及外语水平Computer & Language Skill:
熟练的计算机操作能力
Skilled computer capacity
流利的英语听说读写能力；能够熟练使用专业英语进行语言或文字的技术交流以及论文书写
Fluent in written & spoken English, can skilled use specialized English carries on the language or the writing technological exchange as well as the paper writes