陈雨晴 Email and Phone Number

2020.5 - Present diabetes Phase ⅢResponsible for quality work; Management of CRA team; Supplier management; Facilitate project inclusion;2020.5 - Present PhaseⅠDrug coding and packaging management; Review the project plan; Manage supplier CRO, SMO etc.

2017.5- 2020.5 Autoimmune drugs PhaseⅠPrepare EC submissions；Negotiate study budgets with investigators；Prepara the clinical trail agreements with sites and monitor .2017.12- 2020.5 Antineoplastic agents Phase ⅢAssist to complete data query form; Site close-out visits; Assist the investigator for inspection of project.2016.10- Present Blood biological products. Phase ⅣFacilitate preparation and collection of site level documents; Perform co-monitoring visits according to plan.2017.5-至今 自身免疫类生物制品 Ⅰ期协助完成Ⅰb预实验，预实验已完成，正式试验正在开展，负责伦理资料递交、合同洽谈、遗传办准备、试验物资准备、监查等工作。2017.12-至今 肿瘤类生物制品 Ⅲ期722撤回项目，主要负责与配合第三方稽查，数据答疑，总结报告盖章等关中心工作，协助数据审核会、总结会、国家局核查等。2016.10-至今 血液类生物制品 Ⅳ期协助召开研究者会；机构立项、伦理资料递交、遗传办准备；合同洽谈；启动后协同监查。保证遵循当地法规，ICH-GCP 以及本公司的SOP，管理现有的必要文件；按照要求及时准确的完成临床试验相关的报告。