北京招聘

（Sr.） Clinical Study Manager 临床项目经理

Responsibility:

? Lead and manage a cross clinical delivery sub team to operationally deliver defined clinical studies or clinical project activities to time, cost and appropriate quality.

? Lead the operational delivery of clinical studies, via a team of contributing experts from the study specification to the final clinical study report and archived master file.

? Provide input into study feasibility and study specifications, and produce essential documents including the authoring of clinical study protocols across both interventional and non-interventional studies.

? When working across studies or project work package ensures consistency across the development program.

? To be the interface to partners and oversee the delivery to plan of studies performed through external partners (such as Alliance partners, CROs, vendors and Academic Research Organizations) and to monitor progress, identify and solve operational issues.

? Lead/contribute to clinical submission assembly, regulatory response and payer evidence teams and contributes to advisory board and steering committee meetings.

? Management of changes to project scope and costs (including CRO and other vendors change orders) and reporting project status by participating in project planning and control activities and generation of status reports as required.

? Accountable for agreeing with the project team and functions the most efficient procedures to support delivery by taking the project situation and compliance requirements into account.

Job Requirement：

? University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.

? At least 5 years' experience from within the pharmaceutical industry or similar organization or academic experience.

? Extensive knowledge of clinical operations, project management and processes

? Good experience of clinical development / drug development process in various phases of development and therapy areas.

? Project management certification is desirable but not mandatory.

? Evidence of developing partnering skills

? Ability to learn and Passion to develop team members

    迪哲医药的前身为阿斯利康亚洲及新兴市场创新研发中心，设立于中国上海，是阿斯利康全球四个研发中心之一（另三个中心分别位于英国剑桥、瑞典哥德堡、美国盖瑟斯堡）；是国际一流、高产出的创新药研发机构，拥有全球领先的转化医学和新药分子设计与筛选技术平台；在恶性肿瘤、自身免疫性疾病、肾病等重大疾病的新药研究方面积累了丰富经验。
    迪哲医药，于2017年10月独立运营，是一家研发驱动型生物医药企业，致力于全球创新药物（First-in-class/ Best-in-class）探索、研发以及商业化。
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Dizal Pharma
On Nov. 27th, 2017, through a joint venture between AstraZeneca and China Advanced Manufacturing Fund, Dizal Pharma was co-constructed as a world-leading innovative bio-pharmaceutical enterprise. As a new, unique mode of cooperation between SDIC Fund Management Company Ltd. and worldwide privileged research resources in the field of biological pharmacy, Dizal Pharma can not only accelerate the launch and listing of global new drugs in China, bring Chinese patients access to the latest drugs found across the world at once and thus raise the clinical benefits of patients; At the same time, we also take advantages of the global privileged innovative resources, increase China’s core competitive power in the innovation of new drugs, step in the leading branch of international research and development of new drugs and push China into the role of causing both huge and powerful influence in pharmacy industry.
As a new-style joint venture company, besides the project of the transfer of AstraZeneca’s patents, Dizal Pharma also develops the innovation and creation of global First-in-Class drugs.
The R&D (Research and Development) team of Dizal Pharma was AstraZeneca Asia and Emerging Market Research Center. As one of AstraZeneca’s first four R&D centers across the world, it dedicated to analyze the potential scientific mechanism of those most common diseases in Asia and fulfill the particular medical needs of Asian patients. It was one of the few R&D centers established by transnational pharmacy enterprises in China which had the ability to actually research, develop and produce micro-molecular new drugs, the ability to develop produce new drugs independently and completely, and the first-class medical platform in the world.