岗位职责：此职位是整个公司的关键岗位，在公司的三大主要业务（临床试验，电子病例分析与临床医学项目开发）中均具有举足轻重的作用。希望应聘者具备战略发展的眼光与领导才能，同时秉承脚踏实地的工作风格，更要具备数据管理的专业技能，能以公司的发展为个人目标，高效率的完成日常工作。具体工作职责如下：1. 依据公司的发展规划，制定相应的数据管理相关SOP，工作流程与操作规范。2. 设计病例报告(CRF)的模板，包括字段设定，数据字典和使用手册等；设计纸质病例本与在线系统的结构和内容；并在实际工作中，以GCP/ICP为准，以易用，稳定和高效率为目标不断升级完善，使CRF相关工作达到国际水准。3. 设计，开发，测试及升级，并维护临床试验数据库，以确保数据质量；系统地生成数据query，根据实际情况给出解决方案。4. 协同IT部门，开发测试并完善每个临床研究项目所需的EDC系统，确保该系统满足内部和外部的多重需求；生成数据字典；完善内部逻辑交叉检查；实现高质量的数据采集；整合EDC系统于公司的主系统，并使得其它模块均可与之平行或交互工作。5. 指导临床研究项目组完成纸质病例本的制作，并进行审核；制定CRF与DCF的相关工作流程及SOP，确保完整，一致，清晰和高质量的数据采集。6. 基于不同项目的要求及规范，制定数据管理计划（DMP），并协同项目经理和质控经理，制定对各个CRA的数据管理培训，站点监查，数据原始资料核查（SDV）和数据稽查工作的计划与实施细节。7. 负责数据query相关的工作，制定query计划，提供解决方案，核查query流程，必要时，跟进各个研究点和（或）各个CRA的相关工作进程。8. 作为数据部门的负责人，领导数据部门为临床研究各项目组提供日常工作中的技术指导，并负责解决与解释临床研究过程中遇到的数据管理技术层面的，或者理论基础相关的，或者操作原则方面的问题。9. 在临床研究项目阶段性小结时，负责完成数据质量控制工作的小结与报告的撰写，直至达到客户的要求。10. 在电子病例分析(EMR)等研究项目中，作为临床数据的领导者，全方位的支持项目的推进；并在必要时，直接担任研究项目的总负责人。11. 在临床医学部经理指导下完成工作，并在专业技术层面担当部门其他成员的领导者，负责寻找和发现团队成员的技术薄弱环节，并根据实际制定相应的培训计划。12. 跟进国际当前流行的先进数据管理技术，软件和操作规范及流程；评估并转化可行的内容到实际工作中来。任职资格:大学本科学历，专业计算机，预防医学及生物统计； 3-5年 独立数据库管理经验（有SQL 或/和 ORACLE 工作经验优先）；善于人际交流，善于沟通，善于倾听；善于同时进行多项任务，能在压力下完成工作；能保持独立思维，亦善于团队协作；能高效高质的完成交付的工作任务；被团队视为可以信赖的，机智灵活的，主动热情的领导者；英语熟练者优先。软件技能：1. 掌握临床研究各类规范：FDA, ICH, GCP等等。2. 熟悉Oracle Clinical, Medidata Rave, Phase Forward, Clintrial, SQL and PL / SQL。3. 掌握各种办公软件 (WORD, PowerPoint, VISIO, Outlook)4. 精通CDISC及相关应用。5. 精通SAS (SQL)6. 精通EXCEL (VBA)Position: Clinical data managerResponsibilities This position serves as one of the key roles within the organization, integrating with clinical trial service, EMR study, and clinical development. The qualified individual should have both high level strategic mindset and leadership and down to the ground hands on skills and effectiveness. The candidate should be able to align the corporate objectives and vision with the day-to-day operation.The specific responsibilities include: 1. Aligning with the corporate objectives, develop data management strategy and SOP, as well as data capture regulations, SOP and methods, eg. Electronic data capture (EDC), paper and handheld etc.2. Design CRF, including CRF specifications, annotation, and guidance, whether utilizing paper or electronic formats, according to the protocol while assuring GCP/ICH and industry standard, feasibility, and efficiency.3. Develop, program, test, and maintain clinical trial database ensuring proper edit checks, query generation and resolution, 4. For EDC, collaborate with IT to conduct and oversee the user acceptance testing and EDC modification ensuring satisfaction of internal and external clients; generating data dictionary; assuring internal logic cross-check functions and high quality of data capturing; transferring and integration of EDC into the main system of the company together with other modules.5. For paper based CRF, oversees the entry, review, and cleaning of clinical trial data, manages and tracks CRF's and DCF's (Data Clarification Form) flow, ensuring completeness, consistency and clarity.6. Develop Data Management Plan and coordinate with PM (Project Manager) and QCM (Quality Control Manager) to develop data management SOP, data management training materials, data SDV (source document verification) and auditing procedures.7. Manage query generation, resolution, verification process, including coordination of queries to the clinical trial sites and/or CRAs, as applicable.8. Serve as the data management representative on project teams providing daily support, and serve as the go-to-person for data management related matters, with applying Clinical Data Management principles and knowledge.9. Develop Data Quality Control Report at the end of the study as well as periodical reports during the study, ensuring the data quality and client satisfaction.10. Provide clinical data leadership and support for EMR studies and other clinical development projects, and based on the project, may be assigned to lead the project or be the contact person of a developing project.1