Clinical Research Manager/Assc Manager/Senior Clinical Research Specialist

Clinical Research Manager/Assc Manager/Senior Clinical Research Specialist

Roche
5-8 years
Not Specified

Job Description


Main Tasks and Job Responsibilities
1. Work on the medical clinical research strategy formulation and implementation.
医学临床研究策略的制定实施
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.
领导本地临床研究团队在中国执行所有罗相关的临床研究,并显示越的领导力和专业性。
3.Coordination for the clinical research study and management initiated by customer.
调由客户起的临床研究和管
4. Lead and work with medical affairs colleagues in study plan and protocol design of company sponsored studies.
与医学事务部事共作并主负责进行公起临床研究计划的制定以研究方案的撰写。
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.
负责临床研究的整体实施与管,包括但于研究中心选择,伦审批,研究议签署,研究者会的开,入组,研究文档管,研究中心监查,原始数核查,研究中心关闭,研究报告的撰写和表等。
6. Manage and track the study timeline, study budget and products of company sponsored studies.
管并查看公起研究的时间进度,研究预算和研究产。
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.
建立相关程并负责对研究者起的研究进行审核和跟踪。
9. Work with global MSA and clinical operation team to have cooperation on global multicenter studies.
与罗总部MSA临床研究团队作进行国际多中心研究。
10. Establish and maintain the good relationship with KOLs, investigators and sites.
KOLs以临床研究的研究者良好的沟通。
11. Other projects or tasks assigned by line manager
主管指派的其他任务
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
循罗所有规求,包括但于罗信安全,罗商业中的行为,罗竞争法互动对,罗安全康环境等,法开展业务活动
13. Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook)
了解并执行直线的SHE责(详SHE手册相关定义)
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)
Experience工作验:
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
有丰富的医学临床研究策略的实施验
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

Job Details

About Roche

在罗,自100个国家的100,000员工断推动康医疗行业的进步。我们一工作,使罗为了世界领先的以研为基础的康医疗集团。我们的功于创新求知和多元化,也于我们把相互间的差异作为一优势。为了新医疗康领域,罗设定了远大的计划,学习和展,并断寻找与之志的伙伴。罗供平等的业展机会。

Job Source : www.roche.com

Similar Jobs

People Also Considered

Career Advice to Find Better

Simple body text this will replace with orginal content