【主要職責】: 1. Lead and train the members of your team as well as doing out work; 負責所帶領醫學團隊成員的培訓、帶教、工作分配等日常工作; 2. Write clinical trial protocol, clinical study report and relatedmaterials in clinical study (e.g. the clinical part of IND and NDA, orethical materials), and review the writing of your team Members; 撰寫(包括審核所帶領團隊成員撰寫)臨床方案、臨床研究總結報告及臨床試驗相關材料(包括 IND 或 NDA 中臨床材料、倫理材料); 3. Review clinical trial documents, such as Case Report Form (CRF),Statistical Analysis Plan (SAP), Data Management Plan (DMP) and DrugSafety Report Management Plan and so on. Make sure these documents arecompleted before the deadline; 審核臨床試驗相關文件,包括但不限于:CRF、數據統計分析計劃、數據管理計劃,藥物安全報告管理計劃等,確保在臨床試驗的相關節點前完成; 4. Review medical information, find and solve related medical problemstimely during clinical trials; 在臨床試驗階段,完成醫學審核,及時發現研究中存在的問題并予以解決; 5. Make clinical development plan and complete clinical trial protocoldesign under the leadership of developing directors; 在開發總監帶領下(如有),制定臨床研發計劃、完成臨床研究設計; 6. Solve medical problems and analyze data related to medicine inclinical study. Make sure the clinical study conform to clinical trialprotocol, ICH, GCP and company SOP; 解決臨床試驗中醫學相關的問題以及分析相關數據,確保臨床研究嚴格按照研究方案和 ICH-GCP, 國家相關法規、公司 SOP 進行; 7. Communicate with clinical specialists and CDE reviewers on theproblem of clinical trial design, clinical development strategy and so on; 負責與臨床專家以及與國家藥品審評部門溝通臨床研究設計、開發策略等; 8. To protect clinical projects carried out successfully, you shouldcooperate with operation teams, train them to learn about the medicalpart of clinical study and provide medical support for clinical studyproject startup. 配合運營團隊,對相關人員進行臨床研究相關培訓、項目啟動醫學支持等,以保證臨床研究順利開展。
【Job Description】: 1. Be responsible for the routine work of your medical team; 負責所帶領醫學團隊的日常工作; 2. Be responsible for the pre-IND study design; 負責上市前臨床研究的設計; 3. Be responsible for writing medical materials required in clinicalstudy, including reviewing the writing; 負責臨床研究中所需醫學資料的撰寫(包括審核); 4. Be responsible for solving medical problems and analyzing relateddata in clinical study; 負責解決臨床試驗中醫學相關的問題以及分析相關數據; 5. Be responsible for communicating with clinical specialists and thereviewer from Center for Drug Evaluation (CDE) professionally. 負責與臨床專家及國家藥品審評部門保持專業的溝通。
【資質Qualifications】(Training, Education & Prior Experience): 1. Education required: Specialized master degree of clinical medicine orabove. 學歷要求:臨床醫學專業碩士及以上學歷。 2. Work experience: Clinical Medical Manager with 3+ years relevantwork experience in pharmaceutical company or CRO Company. 工作經驗:在制藥企業或 CRO 公司從事醫學經理相關工作至少 3 年。 3. Ability Requirements: 能力要求: 1) Strong written and oral presentation skills, good at communicating; 具有清晰地書面和口頭表達能力,善于溝通; 2) Strong leadership and execute; 具有較強的領導能力和執行力; 3) The ability to work individually, the collective consciousness withstrong team spirit; 具有獨立工作能力,同時具有較強的集體意識和良好的團隊合作精神; 4) Strong problem-solving ability, good at managing emergency plan; 具有良好的問題解決能力及應急預案管理能力; 5) Good adaptability with the ability to work under reas