Clinical Research Manager/Assc Manager/Senior Clinical Research Specialist

Clinical Research Manager/Assc Manager/Senior Clinical Research Specialist

5-8 years
Not Specified

Job Description

Main Tasks and Job Responsibilities
1. Work on the medical clinical research strategy formulation and implementation.
2. Lead a local clinical study operation team to provide leadership and operational excellence for the execution and conduct of related Roche clinical studies in China.
3.Coordination for the clinical research study and management initiated by customer.
4. Lead and work with medical affairs colleagues in study plan and protocol design of company sponsored studies.
5. Manage the whole study activities, including but not limited to site selection, Ethic's committee review, study agreement signing, investigator meeting, enrollment, trial master file management, site monitoring, source data verification, site close-out and study report writing and publication.
6. Manage and track the study timeline, study budget and products of company sponsored studies.
7. Ensure the clinical studies are in compliance with local regulations, ICH GCP and Roche SOPs.
确所有研究符当地法律法规的求,ICH GCP以罗SOP。
8. Establish and lead local review and tracking processes of investigator initiated studies.
9. Work with global MSA and clinical operation team to have cooperation on global multicenter studies.
10. Establish and maintain the good relationship with KOLs, investigators and sites.
11. Other projects or tasks assigned by line manager
12. 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
13. Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook)
Education& Qualifications教育背景与专业资格:
1. PhD or Master Degree in Clinical Medicine or Clinical Laboratory education background. 临床医学或者临床检验科硕士或士学
2. Clinical Research Qualification in accordance with Chinese laws and regulations, including but not limited to Good Clinical Practice (GCP) (GCP)符中国法律法规的临床研究资质,包括但于临床试验规范标准(GCP)
1.At least 5 years working experience in medical clinical research in pharmaceutical, medical device or IVD companies. 五年以上的在医医疗设备或体外诊断行业的临床研究工作验
2. Excellent People Manager Experience 越的团队领导能力
3. Rich experience in Clinical research strategy implementation
Professional Capabilities/Skills专业能力/技能:
1. Planning & Organizing 计划和组织
2. Internal Cooperation 内部作
3. Medical-related Product & Applications Expertise 医相关的产和应用专业知识
4. KOL Orientation & Relationship Management 方和关系管
Job Level:Manager without direct reports

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