Clinical Database Programmer II 上海

月薪： 12-17万/年

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 弹性工作
  • 定期体检
  • 专业培训
  • 员工旅游
  • 补充公积金
  • 补充医疗保险

职位描述

职位描述： The Database Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to clinical systems, and/or the applications/systems within eClinical technologies. General areas of responsibility also includes: eCRF design, edit check programming and integration of third party systems with the EDC databases. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.Key Accountabilities-Deliver best value and high quality service.- Ensure adherence to service levels agreements with regard to the turnaround time from the point when specifications are finalized.- Ensure quality control (QC) on all process and technical activities related to: trial set-up and maintenance, and/or implementation of system applications and upgrades/changes to those applications as required are performed in accordance with corporate quality standards, SOPs/Guidelines/Work Instructions, ICH-GCP and/or other local or international regulatory requirements.- Check own work in an ongoing way to ensure first-time quality.- Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance.- Proactively participate in quality improvement initiatives.- Ensure compliance with SOPs/Guidelines/Work Instructions, ICH-GCP and any other applicable local or international regulations and participate in internal/external audits and regulatory inspections as required.- Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting and other programming language usage and processes within the GDO and medical areas.- Provide relevant training and mentorship to staff and project teams as appropriate.- Assist project teams in the resolution of problems encountered in the conduct of their daily work.- Create, implement and execute procedures to build and maintain database set-up for paper based and/or web based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable.- Create, implement and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC, following and understanding internal and external regulatory requirements.- Perform small to medium size ad-hoc programming tasks.- Implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved operational efficiencies.- Participate in the creation of standards, either through tools, libraries or processes, as required for GDO to ensure efficient, effective and optimal processes.- Assist in providing technical solutions to internal or external client enquires.- Create Clinical Database documentation.- Support Quality Management efforts through the production and maintenance of technical supporting documentation and ensure that documentation is compliant with corporate quality standards, SOPs/Work Instructions/Guidelines, appropriate regulations and validation requirements.- Coordinate the filing of related documentation in a secure central file repository.- Maintain technical documentation that is applicable to the Clinical Database.- Maintain all supporting documentation in accordance with SOPs/Work Instructions/Guidelines to ensure traceability and regulatory compliance. This includes the documentation of any deviations and dissemination of these to the rest of the project teams. 职能类别： 数据库工程师/管理员 临床数据分析员

联系方式

上海市浦东新区银城中路488号太平金融大厦20层

公司信息

精鼎医药研究开发(上海)有限公司(PAREXEL International)，成立于1982年，是一家致力于药物临床试验研究的CRO (Contract Research Organization)集团公司。总部位于美国，分支机构遍布欧、美、亚、大洋四大洲，且于亚洲13个国家和地区设立了分支机构，致力深耕于当地。精鼎医药由一群具有丰富跨国性临床试验研发经验及专业知识的精英所组成，服务团队集合各种不同专业领域的人才。我们重视与客户的承诺，更重视人才的培育和养成，我们提供完整的教育训练、职涯规划、优于市场的薪资福利、良好工作环境，期许同仁与公司一同成长，迈向未来。 愿景（Vision）： 创造一个在亚太地区具有国际竞争力的最精良CRO团队。 发展使命（Mission）： 1．争取国际大药厂委托，执行符合国际水准的跨国性临床试验。 2．协助亚太生技及制药产业建立新药开发模式，以提升产品研发能力，幷促使产品国际化。 3．以提升临床试验品质为宗旨，拓展全球市场为目标，整合计算机及通讯科技，在国际上提供客户兼具成本效益及效率的临床试验数据处理中心。 4．建立一个以亚洲人种高发生率疾病的基因数据库，以提供国际性新药研发机构所须之基因信息，协助其缩短药物开发时程，幷提高研发成功率。 公司福利和人才培养计划： 保险类： 1. 社会保险(依照国家规定)及住房公积金； 2. 团体保险（包括寿险、意外暨医疗保险）； 3. 补充医疗保险； 制度类： 1. 学习发展计划 (Learning & Development): 针对个别员工之专业及兴趣，设计符合其个人之生涯规划； 2. 完整的教育训练：每年公司均针对所有员工，提供完整之教育训练； 3. 顺畅的升迁管道及可转调其它部门；如有职缺，亦可申请调至海外各子公司； 请 / 休假制度： 1. 服务第一年即享有14天年假, 后续年休假天数则依据服务年资及公司制度而定； 2. 一年可享12天不扣薪病假； 3. 员工旅游, 年度体检； 精鼎医药将以培养国际性的人才为目标，欢迎具有国际观之人才加入。 应聘方法： 1.    在线投递； 2.    请登录我们的公司网站直接投您的简历（https://jobs.parexel.com/search-jobs） 我们在收到您的简历之后，会尽快与您联系。 谢谢！

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