北京招聘

Primarily serves as Regional Medical Advisor but may serve as Global Medical Advisor on assigned projects.

主要作为地区医学顾问,但可以作为全球项目的医学顾问.

Serve as Scientific Advisor and Provides guidance to project Leaders on the medical and scientific aspects of assigned projects.

担任科学顾问和提供指导项目负责人分配的医学和科学方面的项目.

Performs full study protocol and IB

完成完整的临床试验方案和研究者手册.

performs medical review of ICF and CRFs

对知情同意以及病例报告表进行医学审核.

Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.

就方案中的相关问题为研究者及项目人员提供医学支持，包括方案的说明，入选/排除的决定，以及患者安全和/或入选资格的问题等。

Provides therapeutic area/indication training for the project clinical team.

为项目临床团队提供治疗领域/适应症培训.

Attends and presents at Investigator Meetings.

参加并出席研究者会议.

Performs review and clarification of trial-related Adverse Events (AEs).

对试验相关不良事件(AEs)进行审查和澄清.

May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.

与药物警戒部合作，对严重不良事件(SAEs)进行医学审查，包括但不限于病例记录和患者叙述的审查.

May provide medical support for Analysis of Similar Events (AOSE), in in collaboration with or on behalf of Pharmacovigilance department.

与药物警戒部合作或代表药物警戒部为类似事件分析（AOSE）提供医学支持（如有要求）.

May perform medical review of adverse event coding.

对不良事件编码进行医学审核.

Perform full Clinical Study Report (CSR) and review of patient narratives.

完成完整的临床研究报告(CSR)，完成研究中具体病例叙述的审核.

Attends Kick-Off meetings, weekly team meetings, and company meetings, as needed or requested.

根据需要和要求，参加启动会议，每周团队例会及公司会议.

Available 24 hours per day, 7days per week to respond to urgent protocol-related issues at the investigative sites.

全天24小时待命，以回应及处理方案相关的紧急事件.

May provide medical and scientific advises to company proposals: this may include, but is not limited to, protocol feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.

可向主要内部利益相关方提供医学和科学建议，制定提案：这可能包括但不限于方案可行性，目标中心和主要研究者的证明，预期的患者招募情况，治疗的标准和竞争市场等.

Maintains awareness of industry development.

保持对行业发展的认识.

Current knowledge of scientific, clinical, regulatory, commercial, and competitive landscape in applicable therapeutic area.

具有适用的治疗领域的最新的科学，临床，注册，商业和竞争状态的知识.

Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.

了解与临床研究相关的适用的地方法规和指导方针.

Good communication, presentation and interpersonal skills, including good command of English language (both written and spoken).

良好的沟通、表达和人际关系技巧，包括良好的英语听说读写能力.

Ability to establish and maintain effective working relationships with coworkers, managers and clients.

能够与同事、经理和内部/外部客户建立并保持有效的工作关系.

Skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.