Clinical Data Analyst 上海

月薪： 1-2万/月

该公司所有职位
  • 1年经验
  • 本科
  • 招2人
  • 03-04 发布
  • 专业培训
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 定期体检
  • 弹性工作
  • 年终奖金

职位描述

Scope of responsibility Participates in and executes designated data management functions in accordance with PPC and/or sponsor Standard Operating Procedures (SOPs) Responsibility 1. Assist in preparation of Data Entry guidelines for selected project. 2. Understand and follow the Data Management Plan (DMP) with regards to project specific activities related to their function. Perform data entry from CRFs into the clinical database as required, Test data entry screens per data entry guidelines and Case Report Forms (CRFs) for selected projects. 3. Implement DMP changes to daily work activities, reference data issues log to resolve queries whenever possible, generate data queries as directed by the Data Management lead; conduct quality control processes including Case Report Forms (CRFs) to database review. 4. Independently perform data cleaning including query activity and Electronic Data Capture (EDC) reconciliation. Identify and report issues and data trends. Communication with regards to issues and concerns along with suggested resolution. Completion of assigned tasks in a timely manner meeting assigned goals for tasks. Run reports as requested and needed for daily tasks. 5. Reconcile project files, reports, listings and other documents generated in data management against the EDC database for accuracy and completeness of data management processes. 6. Perform all tasks to relevant PPC and/or Sponsor SOPs, ICH or other regulatory guidelines in Data Management . 7. Perform other duties as required by the Department. Qualification(Basic) 1. BSc degree in biological science or a related discipline in the science/healthcare field or equivalent education . 2. Basic knowledge in all technical elements of Data Management . 3. Skilled in Microsoft applications . 4. Basic understanding of medical terminology and clinical research terminology . 5. Basic understanding of medical terminology and clinical research terminology . 6. Communicates effectively through both written and verbal methods . 7. Understanding of ICH-GCP principles . 8. Manages time effectively in order to produce quality deliverables in expected timeframe. Qualification(Priority). 1. 拥有1-2年临床数据管理经验； 2. 了解CDISC相关标准； 3. 有大型项目临床数据管理经验（500受试者以上）。 职能类别： 临床数据分析员 关键字： 临床数据分析 CDA Clinical Data Analyst

联系方式

黄陂南路（地址1号线新天地站，9、10、13号线马当路站）

公司信息

PPC佳生（Protech PharmaservicesCorporation）成立于1997年，致力于为国内外制药企业及生物技术公司提供专业化临床研究服务，为中国大陆、中国台湾、韩国以及日本等亚太地区客户提供临床试验及生物样本检测分析服务。自1997年至今，自成立以来，PPC佳生已为来自全球范围客户完成了2000多个早期临床研究项目（包含新药I期PK、仿制药BA/BE以及生物类似药PK/PD）；并且还执行了超过400个新药后期临床试验项目；所执行的研究方案涵盖24个疾病治疗领域。目前是亚太区域唯一通过日本PMDA、欧盟ANSM、东盟NCPB以及美国FDA核查的临床基地，生物样品实验室开发约300种药品分析方法，以丰富的执行经验提供海内外客户优质服务。2012年，PPC佳生于台北（McKay memorial Hospital）建立了第一家下属I期临床试验中心，并于2016年作为主要投资方与徐州医科大学资源共享，优势互补联合组建合作共同建立了徐州医科大学附属医院I期药物临床试验中心。

上海相关职位

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上海相关职位： 生物制药制剂高级研究员 PK分析副高级研究员 QA高级专员 CMC总监 小分子药物生物分析研究员 工程维护员 临床诊断与试剂部 生物信息学专员 上海医药销售经理 Sr. Technician,Bioprocessing 生物制品研发高级工程师

周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南

企业入驻日期： 2018-02-04

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