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Clinical Research Manager

Job Title: Clinical Research Manager
Contract Type: Permanent
Location: Shanghai, China
Industry:
Salary: Negotiable
Reference: 20200805_1584093003
Contact Name: Cherry Zhu
Contact Email: czhu@profileasia.com
Job Published: March 13, 2020 17:50

Job Description

Summary

Effectively manage the Clinical Research Center in operation, education, training, and quality control. Supervises, plans, coordinates, and evaluates the management of clinical research studies and relevant operating systems.
全面有效的管理临床研究中心的运营、教育、培训和质量控制。监管、规划,协调和评估临床研究项目和相关运作系统。

Essential Job Function
* Lead the effective operation of clinical research activities as designated by the Director of Clinical Research Office in collaboration with principal investigators or study sponsors; identify problems or obstacles in the system/procedures related to the implementation of research protocols and communicate to the study investigator(s); provide overall coordination and facilitation of clinical research activities to ensure patient safety and data 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 and negotiation of study agreement; coordinate the protocol administration including initial protocol submission, subsequent protocol revisions, closure, and termination; communicate closely with the IRB office and ensure timely regulatory reporting and distribution 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 and evaluate staff workload and assignment to ensure compliance with protocol requirements, regulations, GCP, institutional policies, and quality 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 and is responsible for hiring, development, coaching, evaluating, and disciplining of all assigned staff.
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 and statistical process control to facilitate the improvement of clinical research systems and processes.
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。
* Coordinate, plan, and develop training programs for professional and ancillary staff on research protocols, policies and procedures.
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 assigned by 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: Assigned staff
Education
Bachelor of Medicine, Bachelor of Surgery (MBBS), or Bachelor degree in other healthcare-related professions
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 years in clinical research and a minimum of 1 year in supervision or a research 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 and development of new research unit/service is preferred
拥有临床研究中心筹建经验者优先
* May substitute required years of supervisory experience with additional 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 and Certification
* Active medical license, nursing license, or other healthcare-related professional licenses to practice in China is preferred
持有有效的执业医师证书,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 and oral communication skills
优秀的书面和口头沟通技能
* Fluent in Mandarin Chinese and English
流利的普通话和英语