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Job Responsibility
1. Be responsible for the delivery of the studies at allocated sites and works in close collaboration with other CRAs and the local study delivery team to ensure that quality and quantity commitments are achieved in a timely and efficient manner.
2. Conduct site feasibility assessment.
3. Contribute to the selection of potential investigators and leading investigator.
4. Contribute to national Investigator meeting.
5. Obtain and maintain essential documentation in compliance with GCP, ICH-GCP, Company documents and local regulations both in the office and at site.
6. Actively participate in local Study Team meetings.
7. Train, support and advice Investigators and site staff in study related matters.
8. Initiate, monitor and close study sites in compliance with Company Documents. Share information on patient recruitment and study site progress within local Study Team.
9. Drive performance at the sites.
10. Update study related systems with data from sites per required timelines.
11. Manage study supplies, drug supplies and drug accountability at study sites.
12. Perform source data verification. Proactively identify study-related issues and escalates as appropriate
13. Complete monitoring visit reports within required timelines. Document the issues and follow up with sites until it is resolved.
14. Ensure accurate and timely reporting of Serious Adverse Events.
15. Work with data management to ensure quality of the study data. Ensure data query resolution.
16. Prepare for activities associated with audit and regulatory inspection at responsible sites in liaison with local study team lead and QA.
17. Ensure compliance with company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Education, Qualification, Skills and Experience
1. University degree in related discipline, preferably in life science, or equivalent qualification.
2. At least 2 years clinical research working experience in multinational pharmaceutical companies or multinational CROs is preferred.
3. Fluent knowledge of spoken, read and written English.
4. Excellent knowledge of international guidelines ICH/GCP.
5. Good knowledge of relevant local regulations.
6. Good medical knowledge and basic understanding of the drug development process.
7. Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
8. Team oriented and flexible. Ability to manage& prioritize multiple tasks with conflicting deadlines. Ability to work in an
environment of remote collaborators.
9. Meticulous and detail-oriented.
10. Ability to travel nationally as required.
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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.
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。
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。
