临床研究经理

Essential Job Function
• Lea******** effective operation of clinical research activities asdesignate******** the Director of Clinical Research Office incollaboration with principal investigators or study sponsors; identifyproblems or obstacles in the system/procedures relate********implementation of research protocols an******** to the studyinvestigator(s); provide overall coordination an******** of clinicalresearch activities to ensure patient safety an******** integrity.
根据上级的指派，负责与主要研究者或申办方合作，推进临床研究工作的高效运行；发现研究方案实施过程中存在的问题和困难，并及时与研究者沟通；负责临床研究活动的全面协调和推进，确保患者安全和数据质量。
• Assist in the development of study budget an******** of studyagreement; coordinate the protocol administration including initialprotocol subm******** subsequent protocol rev******** closure,an********; communicate closely with the IRB office an******** timelyregulatory reporting an******** of IRB directives.
协助完成研究预算和研究合同；协调方案管理工作：方案提交、方案修正、结题和终止；与伦理委员会办公室密切合作，确保及时完成事件汇报，并及时分配伦理委员会布置的工作。
• Supervise the study conduct an******** staff workloa********assignment to ensure the compliance with protocol re********regulat******** GCP, institutional pol******** an******** measures.
监管研究工作的实施，评估工作人员的工作量和任务分配，确保各项操作均符合方案要求、法律法规、GCP、医院制度和质量标准。
• Set performance expectations for all subordinates an********responsible for h******** ******** coach******** evaluat********an******** of all assigne********.
设置下属的绩效指标，负责招聘、发展、指导、评估、训练下属人员。
• Utilize quality improvement tools an******** process control tofacilitate improvement of clinical research systems an********.
运用质量提升工具和统计过程控制，优化临床研究体系和流程。
• Coor******** plan, an******** training programs for professionalan******** staff on research protocols, policies an********.
协调、规划、开发针对专业人员和辅助人员的培训项目，包括研究方案、制度和流程。
• Other duties as assigne******** the Director of Clinical Research Office.
上级交派的其他任务。

Supervision
Received: Director of Clinical Research Office or designee
Given: Assigne********
Education
Bachelor of Me******** Bachelor of Surgery (MBBS), or Bachelor degree inother healthcare relate********
本科及以上学历，临床医学或其他医药相关专业

Experience
• Minimum of 5 years in clinical practice including a minimum of 2 yearsin clinical research an******** minimum of 1 year in supervision or aresearch administration role
至少5年临床工作经验，包括至少2年的临床研究经验和至少1年的管理岗位工作经验
• Experience in initiating an******** of new research uni******** is preferre********
• May substitute require******** of supervisory experience withadditional years of equivalent experience on a one to one basis.
根据个人情况，管理工作经验可由其他类似的岗位经验代替。

Licensure an********
• Active medical l******** nursing l******** or other healthcarerelate******** license to practice in China is preferre********，护士执业证书或其他医药相关的执业证书者优先
• GCP Certification/证书

Other Requirements
• Excellent written an******** communication skills
优秀的书面和口头沟通技能
• Fluent in Mandarin Chinese an********
流利的普通话和英语