南京招聘

The Database Programmer I /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.

精鼎医药（Parexel International）是全球领先的药物研究合同委托机构（CRO），总部位于美国生物医药圣地马萨诸塞州的波士顿附近，在世界各地拥有71个办事处，约17,600 名员工，为超过100个国家的客户提供服务。

精鼎医药成立于1982年，在三十多年的历程中，一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商，并且取得了卓越成果。目前，我们能够提供全世界CRO领域全面的新药临床阶段研发服务，服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。

将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案，可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。