Clinical Operation Manager
卫材（中国）药业有限公司
- 公司规模：1000-5000人
- 公司性质：外资(非欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2019-09-23
- 工作地点：北京-朝阳区
- 招聘人数：1人
- 工作经验：无工作经验
- 学历要求：本科
- 职位月薪：2-3万/月
- 职位类别：临床研究员
职位描述
Job Responsibilities:
1.Acts as the China/Regional Lead for the designated global/regional studies and assists the Senior Manager/Manager, Clinical Operations in the daily operational matters related to the execution, management and monitoring of the trials, such as review of informed consent forms, participating in site PSSVs, co-monitoring visits, close-out visits, drafting of these visit reports, review of IMP packages, etc. so as to ensure that the defined timelines and milestones are being met in a timely and efficient manner.
2.Assists the global/regional project teams to provide technical and content expertise within China/Asia Pacific region during the course of the study, as well as identifying potential challenges and working with team to strategize possible solutions.
3.Assists the Senior Manager of Clinical Operations in CDD to enhance process, functional and operational efficiencies in the clinical development of their designated global/regional trials through sharing of information, best case examples etc. within JAC PCU and across the different PCUs
4.Provides general CRO/vendor oversight in the management and progress of their designated global/regional trials in China/Asia Pacific region
5.Participates in projects and initiatives relating to better understanding of patient reality and hhc within area of work
6.Assist in the improvement of EPCS committees and processes.
Education and Experience:
？4-5 Years of pharmaceutical and/or CRO experience in the capacity of a Project Lead / Project Manager
？Experience in handling multiple tasks
？Strong personnel management experience is required
？Bachelor’s degree required in associated scientific discipline
？Master’s degree, PhD, or RN degree preferred
1.Acts as the China/Regional Lead for the designated global/regional studies and assists the Senior Manager/Manager, Clinical Operations in the daily operational matters related to the execution, management and monitoring of the trials, such as review of informed consent forms, participating in site PSSVs, co-monitoring visits, close-out visits, drafting of these visit reports, review of IMP packages, etc. so as to ensure that the defined timelines and milestones are being met in a timely and efficient manner.
2.Assists the global/regional project teams to provide technical and content expertise within China/Asia Pacific region during the course of the study, as well as identifying potential challenges and working with team to strategize possible solutions.
3.Assists the Senior Manager of Clinical Operations in CDD to enhance process, functional and operational efficiencies in the clinical development of their designated global/regional trials through sharing of information, best case examples etc. within JAC PCU and across the different PCUs
4.Provides general CRO/vendor oversight in the management and progress of their designated global/regional trials in China/Asia Pacific region
5.Participates in projects and initiatives relating to better understanding of patient reality and hhc within area of work
6.Assist in the improvement of EPCS committees and processes.
Education and Experience:
？4-5 Years of pharmaceutical and/or CRO experience in the capacity of a Project Lead / Project Manager
？Experience in handling multiple tasks
？Strong personnel management experience is required
？Bachelor’s degree required in associated scientific discipline
？Master’s degree, PhD, or RN degree preferred
职能类别：临床研究员
公司介绍
卫材在华企业隶属于卫材株式会社，卫材株式会社是一家以研究开发医药产品为主的跨国公司，总部设在日本东京。
卫材中国自上世纪90年代初进入中国市场以来顺利发展壮大。自1991年先后成立沈阳卫材制药有限公司和卫材（苏州）制药有限公司，并于2002年正式更名为卫材（中国）药业有限公司。伴随着中国业务的发展，于2010年成立卫材（苏州）贸易有限公司，于2014年成立卫材（中国）投资有限公司，并于2015年通过全额收购本地仿制药企业正式成立卫材（辽宁）制药有限公司。至此，形成了以卫材（中国）投资有限公司为资控管理，以卫材（中国）药业有限公司、卫材（辽宁）制药有限公司、卫材（苏州）贸易有限公司为业务支撑的发展模式。为适应中国业务的快速发展，2014年11月卫材（中国）药业有限公司注射剂工厂竣工， 2017年11月新固体制剂厂房落成，卫材中国的产能得到迅速提升。
目前，总注册资本10,854万美金。已形成以神经科学领域、肿瘤（特药）领域、消化肝病领域为重点领域，拓展仿制药领域，多达数十种药品在中国销售的发展规模。
未来，苏州工厂除满足中国患者临床用药的需求外，将向亚洲其它国家和地区同样提供高品质满足患者需求的产品。另外，卫材中国的销售额已连续十余年保持在华日资制药企业的***位置。
特别提醒：在候选人未正式入职前，卫材（中国）药业有限公司不会安排其参加任何培训，更不会向其收取任何费用，请应聘者谨防受骗。
卫材中国自上世纪90年代初进入中国市场以来顺利发展壮大。自1991年先后成立沈阳卫材制药有限公司和卫材（苏州）制药有限公司，并于2002年正式更名为卫材（中国）药业有限公司。伴随着中国业务的发展，于2010年成立卫材（苏州）贸易有限公司，于2014年成立卫材（中国）投资有限公司，并于2015年通过全额收购本地仿制药企业正式成立卫材（辽宁）制药有限公司。至此，形成了以卫材（中国）投资有限公司为资控管理，以卫材（中国）药业有限公司、卫材（辽宁）制药有限公司、卫材（苏州）贸易有限公司为业务支撑的发展模式。为适应中国业务的快速发展，2014年11月卫材（中国）药业有限公司注射剂工厂竣工， 2017年11月新固体制剂厂房落成，卫材中国的产能得到迅速提升。
目前，总注册资本10,854万美金。已形成以神经科学领域、肿瘤（特药）领域、消化肝病领域为重点领域，拓展仿制药领域，多达数十种药品在中国销售的发展规模。
未来，苏州工厂除满足中国患者临床用药的需求外，将向亚洲其它国家和地区同样提供高品质满足患者需求的产品。另外，卫材中国的销售额已连续十余年保持在华日资制药企业的***位置。
特别提醒：在候选人未正式入职前，卫材（中国）药业有限公司不会安排其参加任何培训，更不会向其收取任何费用，请应聘者谨防受骗。
联系方式
- Email：eisaihbhr@eisai.com.cn
- 公司地址：武汉市建设大道568号新世界国贸大厦