北京招聘

Major Tasks of Position:

DM Expertise

- Serves as the key subject matter expert on topics related to data management activities including specific activities and processes in early clinical development phases. Contributions include, but are not limited to: vendor selection and management, mentoring junior staff, training team members, leading or contributing to expert working groups, presenting best practices at internal and external industry meetings meetings/congresses, and participating in due diligence assessments.

- Ensures adequate application of Data Management Best Practices across studies within assigned projects: review Study Team documents for project consistency; ensure the adequate documentation of all data management activities according to SOPs.

- Implement/setup/application/approval all design of eCRF/EDC.

Lead DM tasks

- Assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and apply Data Management best practices

- Accountable or a contributor for CDM deliverables from protocol creation until release of data for analysis.

- Ensure CDM input and contributions to Risk Management (risk identification, risk communication, incorporation of risk in risk management plan, implementation of risk mitigation activities in relevant plans)

- Incorporates and maintains Medical Standards in clinical studies for all elements of the medical standards package.

Operational Data Management

- Supports study data management and data cleaning processes on an ongoing basis, applying study specific documents and conventions.

- Identifies and issue queries, incorporate query replies and track query status.

Other tasks

- Cooperate with DMPL, Database programmer, IT to setup RAVE system.

任职要求：

- Master degree (or equivalent/higher), preferably in the fields of Natural Sciences, Life Sciences, Informatics, Medical Documentation or related subject [Equivalent degrees such as state certifications/graduations might also be accepted; relevant work experience might be acceptable instead of a degree, where relevant is defined as a minimum of 3 years of relevant Data Management experience.]

- At least 3 years of study and/or project level experience as a Data Manager in supportive and leading roles, or as a project-leading role in a scientific, data-driven position in the medical research area.

- At least 2 years of experience should demonstrate full responsibility as a Lead Data Manager, or equivalent roles in in a scientific, data-driven position in the medical research area.

- Good understanding of the drug development process, understanding of relevant research processes.

- Strong organizational skills and able to collaborate with minimal supervision.

- Ability to work effectively in a global environment. Essential competencies identified include: Customer Focus, Drives Results, Plans & Aligns. Other key capabilities like Collaborates, Instills Trust, and Manages Complexity should be also displayed by the incumbent.

- Significant experience in using data management methodologies and technologies (e.g. Electronic Data Capture Familiar with data warehousing, and working in a SAS environment).

- The incumbent is required to conduct him/herself in an appropriate business manner adhering to a high ethical standard.

    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。
    详情请点击公司官方网站：**************************/

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.