南京招聘

Deliver best value and high quality service.
Ensure quality control (QC) on all process and technical activities related to:
- trial set-up and maintenance, and/or derived dataset, table, listing, and figure programming and/or implementation of system applications and upgrades/changes to those applications as required in accordance with corporate quality standards, WSOPs / Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
-Check own work in an ongoing way to ensure first-time quality.
-Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
-Proactively participate in quality improvement initiatives.
-Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and 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, SAS and other programming language usage and processes within the GRO, biostatistics, and medical arenas.
-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.
-Assist in the coordination of project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
-Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents.
-Use efficient programming techniques to produce and/or QC low-medium complexity derived datasets, tables, figures and data listings.


Experience:
First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience.
Excellent written and oral communication skills.
Relevant Clinical Trial industry experience
Experience working with systems used within the Clinical Trial process (e.g., SAS, CDMS, EDC (Inform, RAVE, DataLabs), CTMS, Medical Safety Reporting)

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。