• 2年经验
  • 本科
  • 招2人
  • 02-09 发布
  • 五险一金
  • 补充医疗保险
  • 专业培训
  • 年终奖金
  • 弹性工作
  • 定期体检
  • 通讯补贴
  • 餐饮补贴
  • 交通补贴

职位描述

Requirements Responsible for processes related to the setup and support of clinical database and/or other associated processes in support of data cleaning and data review activities. ResponsibilityLead the design and build of study database or other data management related systemEnsure awareness of project-specific quality and performance standards and ensure that these are adequately documented, communicated and understood. Provide training support for training sessions and workshops Maintain awareness of current development in the therapeutic areas relevant to his/her project(s), by reading scientific and medical literature. Perform all tasks to relevant PPC and/or Sponsor SOPs, ICH or other regulatory guidelines in Data Technologies and ProgrammingProvide guidance or training for fresh programmer staffPerform other duties as required by the Department qualifications and experienceDegree in a mathematical, computing, life sciences, or related discipline Minimum 2 - 4 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job Ability to maintain confidentiality of data and information during interactions with staff at all levels Knowledge in at least 2 clinical database system and/or Knowledge of basic SAS programming skills to perform transfers, external checks, listings and process external vendor dataUnderstanding of the roles of standards, including CDISC Good oral and written communication, organizational skills.Understanding of the principles of ICH GCP and regulatory requirements especially as they relate to data management activities 职能类别: 临床研究员 生物工程/生物制药 关键字: 数据库程序员 临床数据 Study Builder

联系方式

黄陂南路838弄

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。

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