北京招聘

Plan and Lead the Delivery of all components of a clinical study to time, cost, and quality from Study Specifications through study closeout activities and Clinical Study Report.

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.

13. Perform any required co-monitoring & QC visits with study monitor(s)

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.

17.   Communicate and co-ordinate regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters.

18.   Coordinate the process for selection of potential Investigators considering capability, competence, etc, of the Hospitals/sites.

19.   Plan and lead national Investigator meetings, in line with local codes. Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.

20.   Work in close coordination with Study Drug Coordinator to create a robust Drug Consumption Plan.

21.   Ensure completeness of the Study Master File and ensure essential documents are sent.

22.   Ensure local Serious Adverse Event (SAE) reconciliation takes place.

23.   Facilitate translation of documents (ICFs, patient diaries, participation cards, etc) through external providers.

24.   Ensure timely submission of proper application/documents to EC/IRB. Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority.

25.   Set up and maintain the study in CTMS at study country level.

26.   Ensure accurate payments related to the study are performed.

27.   Participate in training and coaching new members of the Local Study Team ensuring compliance with ICH/GCP and DZ Procedural Documents.

28.    Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Study Master File.

29.    Plan and lead activities associated with audits and regulatory inspections. Provide input to process development and improvement.

30.    Provide regular information to Line Managers on study and planned study milestones/key issues.Update Line Managers about the performance of the monitors/CRAs.Ensure that study activities at country level comply with local policies & code of conduct.

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)

3.    Excellent knowledge of spoken and written English.

4.    Good ability to learn and to adapt to work with IT systems.

    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.