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職責描述:
Job description.
1、負責臨床試驗項目運營與管理、監(jiān)查報告的技術審核:
1. Be responsible for the operation and management of clinical trial projects and the technical review of monitoring reports.2、從整體上分配和協(xié)調資源，把握項目進度，確保項目在預算時間和成本內優(yōu)質高效完成，
Acat and coardnate esources as a wh asn the mroiet arores and ensur thate rnect is coed wt hon aualit and efcenay wthn the budneted timne and cos
3、負責項目管理部的營運及日常管理、績效考核、技術指導和培訓;
3. Be responsible for the operaton and daly management, performance appraisa, technica guidance and training of the proiect management department
4、負責部門管理制度及SOP的制定、監(jiān)督執(zhí)行:
4. Be responsible for the formulaion, supervision and implementation of department management system and SOP
5、完成總經理交辦的其他工作。
5. Complete other tasks assigned by the general manager.
任職要求:
Job requirements.
1、碩士學歷，臨床醫(yī)學、藥代動力學、生物藥劑學等相關專業(yè)
1. Master degree. major in clinical medicine. pharmacokinetics, biopharmaceutics, etc
2、8年以上國際或國內大型藥企、CRO公司類似崗位任職經歷:
2. At least 8 years working experience in similar positons in large interational or domestic pharmaceutical enterprises and cro companies.3、豐富的創(chuàng)新藥1&II&l期項目管理、監(jiān)查或稽查經驗，熟悉ICH/GCP、FDA/CFDA有關臨床試驗的相關法規(guī);
3. Rich experienc in management, supevision orinspection of imovatve drugs phase 1 & 1 & lproiects, and tamilar with relevant regulatons of lCH/ CCP and FDA/ CFDA on cinic
4、具有較強的領導能力、判斷能力和溝通能力、應變能力:
4. Strong leadership.iudgment. communication and adaptability
5、具有良好的英文聽說和寫作能力;
5. Good English listening. speaking and writing skills.
6、強烈的事業(yè)心與使命感、持續(xù)的自我驅動力、個性陽光、開朗。
6. Strong dedication and sense of mission, continuous self driving force, sunny personality and cheerful