临床开发经理 (职位编号：TP04903)社

面议

市辖区7年及以上

发布时间：2023-09-06

职位描述

Job Responsibility
- Acts as the Lead for the designated studies and assists the manager 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
- 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
- Assists the Senior Manager/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 CDD and across the different PCUs
- Provides general CRO/vendor oversight in the management and progress of their designated global/regional trials in China/Asia Pacific region
- Participates in projects and initiatives relating to better understanding of patient reality and hhc within area of work
- Assist in the improvement of EPCS committees and processes, wherever possible
Qulifications
- Working knowledge of entire drug development process, including clinical plan
development and execution of entire clinical study chain, specifically within the China/Asia Pacific region
- Detailed
knowledge of Code of Federal regulations (CFRs), ICH guidelines, clinical operations, project management, and corporate /regional SOPs
- Demonstrated ability to manage and coach reports who are CRO project managers and individual contributors
- Good organizational, time management and attention to detail skills
- Extremely proficient computer skills including MS Word, Excel, and PowerPoint
- Strong verbal, written and interpersonal communication skills, especially needed to work effectively in a cross-functional and cross-cultural team environment,
managing that team as required
Requirements
- 1-2 Years clinical research experience in a pharmaceutical company and/or CRO in the capacity of a Project Lead / Project Manager
- Experience in handling multiple tasks and strong personnel management experience
- Bachelor’s degree required in associated scientific discipline, or Master’s
degree, PhD, or RN degree prefer**********************

其他要求

招聘人数：1人
职能类别：临床监查员CRA

公司介绍

卫材药业（EisaiChinaInc.）
卫材（Eisai）系世界知名医药跨国企业，本着“为人类健康保健服务-HumanHealthCare”的宗旨，于1996年在苏州工业园区投资成立了独资制药企业——卫材（中国）药业有限公司，其注册资本为3854万美元，总部设在上海，并已在全国设立了11个办事处和1个生产基地。目前，卫材在中国的产品主要涉及神经系统、消化系统、心血管系统等领域。
为配合中国地区业务发展之需，现诚邀有志于与卫材共同发展的您加入我们的大家庭！

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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。