岗位要求： 医药、临床相关专业，毕业于医学、药学类专业著称的知名大学； 在制药企业或CRO公司至少3年相关工作经验，至少2年项目管理经验； 英语六级以上或海外求学经历，具有良好的英语听说读写能力； 熟练应用office软件，熟悉网络工具的各种应用. 岗位职责： 主要工作职责key responsibilities : 1.参与制定新产品临床研究策略，保证得到RA部门经理及总部医学部门的批准 participating in making study strategy of new product clinical trial, ensure it get approval from local RA manager and related dept of HQ. 2.负责新产品临床研究组织，实施和临床监察的计划制定及项目管理，保证此过程符合国家及总部GCP的要求； Be responsible for new product clinical project planning and management, including sponsoring, conducting and monitoring, ensure this procedure is in compliance with GCP requirement of SFDA and HQ. 3.审核修改临床研究协调员撰写的临床研究方案，病例表格等研究文件，保证得到RA部门经理和总部相关部门的批准； Review and revise clinical documents like protocol, case report form, etc, ensure it get approval from RA manager and HQ’s clinical dept. 4.组织完成临床的各期研究者会议，促进临床研究的如期进行； Organizing and conducting each phase investigator meeting, promote on time completion of clinical trial. 5.审核修改临床研究协调员撰写的临床研究总结报告，并符合国家药品注册的要求； Review and revise clinical study report, ensure it meet the registration requirement of SFDA. 6.做好与临床基地间的沟通与协调； Make good communication and associate with clinical study site. 7.配合完成公司产品注册相关工作； Cooperating with other dept to finish new product registration. 8.深入了解产品及相关的医学专业背景，为市场部、销售部、培训部提供相关产品的医学支持，包括审核促销资料，审核药品说明书以符合总部相关要求； Deep understanding of product and its background medical knowledge, provide medical support to marketing, sales, training dept, including review and approval of promotion material, reviewing product information to make sure it in accordance with HQ requirement. 9.负责与药政部门协商有关临床研究的技术事宜； Be responsible for discussing clinical research technical issues with SFDA. 10.按照国家和总部的要求，协助安全事务专员，负责我公司药品的临床试验中的不良反应监测和报告； Assist safety advisor, responsible for product pharmacovigilance to ensure it meet the requirement of SFDA and HQ safety dept, deal with ADR by cooperating with other dept.