Associate Clinical Research Manager

中国, 上海, Shanghai

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Main Tasks & Responsibilities主要工作职责 :

1. Provides leadership in complex clinical research activities including: reaching agreement on study goals with other functional areas, coordinating and overseeing study monitors and investigators to ensure compliance, monitoring, analyzing and interpreting study data, and preparing reports.  

领导临床研究的复杂活动,包括:与其他职能领域就研究目标达成一致,协调和监督研究监测员和研究人员,以确保合规,监测,分析和解释研究数据,以及准备报告。 

2. May contribute to the design of clinical studies. Independently plans and implements complex or significant clinical research studies and projects.   

可有助于临床研究的设计。 独立计划和实施复杂或重要的临床研究和项目。 

3.Ensures that goals and activities of own work or project team is aligned with the objectives of the area(s) and the organization.  

确保自己的工作或项目团队的目标和活动与区域和公司的目标保持一致。

 

4. Assumes responsibility for coordinating the activities of relevant colleagues within the company and investigators to ensure compliance with the overall scientific objectives.  

负责协调公司内部相关同事和研究者的活动,以确保符合整体科学目标。

 

5. Lead feasibility and regulatory submission (e.g. HGRAC, EC and/or NMPA submissions), execute monitoring plan, oversee, develop and implement CAPAs. 

领导可行性和监管提交(e.g. HGRAC,EC 和/或NMPA 提交),执行监督计划,监督,制定和实施CAPAs 

6. Travels to field sites to monitor studies or coach and train co-workers at the CRA level and below to ensure they are in compliance with regulations, SOPs and study protocols.  

到研究中心检查公司的研究项目 或 指导和培训 CRS 及以下级别的同事进行检查以确保他们遵循法规,SOP和试验方案。 

7. Work with project responsible, Medical Writer, Data Management and Bio statistical staffs on the design of study protocols, reports and other study documents like ICF. Contribute technical and clinical operations expertise for these documents and clinical operation SOPs.  

与项目管理,医学撰写,数据管理和生物统计人员合作设计研究方案,报告和其他试验相关文件如知情同意书。为这些文件提供技术和临床操作专业知识和临床操作SOP (如适用)。 

8. Works with Data Management and Bio statistical staffs on the design of documents and processes for the collection of study data from participating sites.  

与数据管理和生物统计人员合作,设计从参与地点收集研究数据的文件和程序。 

9. Develop and maintain study supplies/instruments plan of assigned studies, monitor the supplies/instruments ordering, distributing, storage, reconciling and recycling or destroying.  

制定和维护试验物资和设备管理计划,并监管。

10. Ensures accurate and complete study management/data collection and transfer to data management. Collects and maintains legal and regulatory documentation, as applicable.  

确保准确和完整的研究管理/数据收集和转移到数据管理。收集和维护(如适用)法律和法规文件。 

11. Coordinates or conducts reference material testing in-house. 

在内部协调或进行参考材料测试。

12. Organizes investigator meetings, as necessary. 

必要时组织研究者会议。

13. May represent the company as primary contact on projects and conduct other projects or tasks assigned by line manager. 

可代表公司作为项目的主要联系人和完成主管指派的其他任务。 

14.If apply, develop and maintain a good working relationship with BAs and other dept. to support the cross-functional projects  

如使用, 开拓并维护与业务部门和其他部门的良好工作关系,以支持跨部门项目。 

15. Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection 

遵循罗氏所有合规要求,包括但不限于罗氏信息安全,罗氏商业中的行为,罗氏竞争法互动对话,罗氏安全健康环境等,合法合理开展业务活动。

Education& Qualifications教育背景与专业资格:

1. At least Bachelor degree in medical science, preferably in clinical medicine, medical laboratory, biochemistry, pharmacology, bio-engineering and biology  医学专业本科及以上学历,优先临床医学,医学检验,生物化学,药学,生物工程和生物学 

2. Proficiency in English language skills 熟练掌握英文技能  

3. Good command of MS office software application 熟练应用微软办公软件 

4. Understand pharmaceutical and/or medical device regulation and ICH/GCP 

了解药品及/或医疗器械法规和ICH/GCP    

Experience工作经验:

1. At least 5 years of working experience in clinical research, clinical project management, data management in clinical medicine, CRO, pharmaceutical, Medical Device, or in-vitro Diagnostics industries 

临床医学,CRO,制药,医疗器械或体外诊断行业至少 5 年的临床研究,临床项目管理,或临床数据管理相关工作经验 

2. Effective oral and written communication skills; able to get ideas across face-to-face, in group settings as well as in presentation 

高效的口头及书面沟通技巧; 能够在面对面,小组设置和演示中获得想法 

Travel Requirements 出差要求: 

Approximately 30% of time local and/or international travel. 

大约30%的时间是本地和/或国际出差。