- 无工作经验
- 本科
- 招1人
- 11-09 发布
职位描述
职位描述: The incumbent will be responsible for mainly China study management aspects of a clinical study including but not limited to all of the tasks specified below. For all of the regional study activities in a global study, the incumbent will work with the OSL/SnrCTM/POL to ensure correlation of global study activities.Study Concept, Planning and Strategy PhaseThe incumbent is responsible for: ensuring regional study feasibility in collaboration with the OSL/SnrCTM/POL including summarizing regional assessment of patients and resource; initial assessment of vendors needed; and the development of regional specific study timelines.Study Initiation PhaseThe incumbent is responsible for: region-specific document development; assessing local vendor requirements and liaising with appropriate departments on vendor selection; ensuring the development of regional enrollment initiatives; input any regional specifics to the global study budget via the OSL/SnrCTM/POL; planning regional clinical study supplies.Study Management/Conduct PhaseThe incumbent is responsible for: China investigator meetings/presentation of materials; regional financial management; database lock activities; regional study drug management; regional trial master file; regional study enrollment management (e.g. contingency plan execution); ongoing review of protocol deviations; regional vendor management; ensuring compliance of serious adverse event reporting. Close-Out Phase The incumbent is responsible for: supporting database lock activities; ensuring all regional documents are filed in the CSR sections appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed. Pls contact Jenny Zhang via jenny.zhang@docsglobal.com. 职能类别: 临床研究员
联系方式
北京市东城区北三环东路26号环球贸易中心
公司信息
ICON Clinical Research-- a top global CRO company. For more details, please kindly see our website - http://www.iconplc.com/
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