（Sr.）医学经理

岗位职责:

As a Senior Medical Manager, the individual will be assist with the development and execution of medical monitor strategy and plan to provide medical monitoring in accordance with the internal and external priorities and requirements, and in strict adherence to the company

s corporate policies, guidelines and requirements.

MAIN RESPONSIBILITIES

•To provide overall medical and safety oversight of clinical trials as assigned.

•To contribute the clinical study extended synopsis based on feasibility pre-assessment, protocol complexity index and associated cost with professional medical and study-specific knowledge.

•To interact with inter-departmental and external consultants, investigators, and regulatory agencies as appropriate.

•To assist with supervising the medical and safety monitoring activities, including but not limited to clinical lab values, AEs, coding dictionaries and data tables, listings and figures.

•To insure medical answers to the questions from Health Authorities, IRB/Ethics Committees, Investigators, experts, clinical study team timely and appropriately.

•To review/approve medical-related documents (e.g. specifications for centralized services, Protocol, ICF, CRF, CRF completion guidance, patient diary, etc.).

•To provide project-specific and therapeutic training to sponsors and company staff as needed.

•To assist with maintaining the in-depth knowledge of CFDA and worldwide drug-development regulations, national and ICH Good Clinical Practice (GCP) guidelines.

任职要求:

•Master Degree or above in clinical medicine, Ph.D. or M.D. is a plus

•Around 3 years’ work experience and 1 years of medical monitoring

•Fluent verbal and written English (equals to CEF C1, BEC H, IELTS 7.0，CET-6)

•Ability to work independently and handle multiple tasks simultaneously under pressure

•行业经验：至少2年医生经验外加至少3年甲/乙方企业经验

•岗位经验：如果有眼科项目或眼科医生经验优先

•Good communication skills and good team player

•Ability to coach other medical monitors

•Global, cross-cultural perspective and customer orientation

LOCATION

•Beijing, Shanghai (Tianjin, Guangzhou, Wuhan, Chengdu can also be considered) or（远程办公）