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Responsibilities:
1. To lead Local Study Team at country 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.
2. Provide co-monitoring to CRAs to ensure study quality reaching/above global level.
3. Develop and maintain excellent working relationships with external and internal customers to ensure the smoothly and timely delivery of clinical studies.
4. In addition to leading LST(s), LSTL is expected to perform site monitoring if needed.
5. As part of the flexible capacity model it is expected that LSTL manages both roles.
6. LSTL is responsible to ensure that sites are identified, site qualifications performed,
set up, initiated, monitored, closed and documentation archived.
7. Overall responsibility for the study commitments within the country, for timely delivery of data to required quality.
8. Contribute and support global study lead on overall study deliveries.
9. Lead Local Study Team(s) consisting of monitors and study administrator(s).
10. Lead and optimise the performance of the local Study Team(s) at country level ensuring compliance with DZ Procedural Documents, ICH-GCP and local regulations
and to update other study team members on study matters.
11. Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from
respective Study Team.
12. Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on
study related matters.
Proactively identify and facilitate resolution of complex study problems and issues.
14. Organise regular Local Study Team meetings on an agenda driven basis.
15. Actively work towards achieving good personal relationships with all local Study Team
members.
Report study progress/update to the SMO Study Leader/Team.
16. Contribute to patient recruitment strategy including regular communication with concerned
Investigators as necessary.
Minimum Requirements and Preferred Background
1. Minimum University degree and / or equivalent, preferred in biological science or healthcare-related field.
2. Minimum 4 years experience in Clinical Operations or other related fields (Medical Affairs-led studies or Academic-led studies)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。