北京相关职位： 实习生 医学经理 医学总监 临床项目高级经理 体外诊断试剂生产主管 QC (职位编号：05003) 医疗器械注册主管/经理 (职位编号：05002) 高级研发经理 (职位编号：01001) 招商总监 科研服务销售
周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2018-01-08
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3-4年经验 -
本科 -
招1人 -
01-08 发布
- 五险一金
- 补充医疗保险
- 出国机会
- 专业培训
- 年终奖金
- 定期体检
职位描述
Job Description:1. Clinical Research?Identify and develop research strategies for products?Develop appropriate protocol synopsis and protocols to support research proposals and meet local registration needs?Actively participate feasibilities at program, protocol and site level for global/regional studies, and provide timely and quality feedback?Translate final protocols and amendments for global/regional studies?Assist with Study Manager (Operational Lead) in Coordinating Principal Investigator and leading site selection?Develop local ICDs (Informed Consent Document), and translate as needed?Prepare and deliver presentations for product and protocol introduction at Investigators Meeting and answer related questions from investigators?Review and provide comments on study documents as required?Act as Protocol Lead and Clinical Lead in a study team, approve protocol deviations, analyze AEs/SAEs, and answer clinical and product queries from investigators?Provide valuable inputs in SAP (Statistical Analysis Plan) finalization and efforts in achieving Database clean?Prepare and finalize local clinical study report, and assist NDA submission?Maintain high level of clinical understanding to products?Provide disease and protocol training to monitors as needed?Establish and maintain an effective network of relationships with key opinion leaders2. New product registration?Translate and prepare clinical section of IND submission dossier (e.g. IB, study reports from previous clinical trials, clinical summary)?Prepare clinical related response to SFDA/CDE for any queries as required?Prepare slides and deliver presentations of clinical section to CDE Review Meeting as requiredJob Requirements:. Educational / Training?University Degree and Medical qualification?Advanced Degree in biomedical sciences (MSc, PhD) preferred2. Working Experiences?At least 3 years clinical experience1?At least 2 years international pharmaceutical industry experience?Experiences in assigned therapeutic areas is preferred?Knowledge of Chinese/ICH GCP guidelines?Knowledge on drug development process?Knowledge of clinical trial methodology?Knowledge of country regulatory environment?Proficiency in Basic Microsoft Word, Outlook, PowerPoint and Excel 职能类别： 生物工程/生物制药 临床研究员 关键字： Clinical Research Physician 临床研究医生
联系方式
北京市 西城区
公司信息
西藏晨泰医药科技有限公司成立与2017年1月，在上海、北京有办公室，目前主要从事肿瘤药物开发。
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