北京招聘

Primarily responsible for coordinating the various aspects of clinical trials. Works as part of a clinical delivery team providing support, guidance and advice on a local level.  Develops existing tools and processes to identify areas of improvement and ensures business continuity for study delivery. Able to solve complex problems within a range of studies.

Responsibility

1. Contribute and support global study lead on overall study deliveries. Ensures the processes for Study Delivery are executed through the development of study reports tools, facilitation of the study delivery system and maintenance of the system which including but not limited to Central lab, Central imaging, Central ECG, IXRS, ePRO etc..

2. As an expert, ensures delivery of a centrally managed study management service across clinical studies from start up to reporting.

3. To lead study activity at regional level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with DZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.  

4. Develop and maintain excellent working relationships with external and internal customers to ensure the smoothly and timely delivery of clinical studies.

5. Initiates and maintains production of study documents, ensuring template and version compliance.

6. Manages and coordinates tracking of study materials and equipment.

7. Monitors administrative tasks during the study process, audits and regulatory inspections, according to company policies.

8. Acts as a technical owner within Patient Safety with a deep understanding of processes and internal regulations.

9. Keeps own knowledge of best practices and new relevant developments up to date.

10. Liaises with compliance team members to improve regulatory processes within the team.

11. Identifies opportunities to improve the methodology and provide practical solutions for clinical development.

Education, Qualifications, Skills and Experience

1. At least bachelor’s degree in relevant discipline.

2. Minimum 5 years experience in clinical research  , at least 2 years experience in international company taking project management or leading CRA role.

3. Excellent knowledge of spoken and written English.

4. Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management.

    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.