南京招聘

工作职责:

ummary:

Ensure the high quality and efficient data acquisition in database and data cleaning support by performing/overseeing/being responsible of data management documents development, eCRF screen set-up, edit-checks programming, manual listing generation, data transfer and all the other related tasks on the basis of WuXi Clinical and/or sponsor Standard Operating Procedures (SOPs).

Accountability:

Study Start-up

？ Create and maintain study documentations under supervision, including but not limited to study protocol, (e)CRF, Data Validation Plan, CRF Review Comments Log, Push to Production Checklist, Database Modification, Database Validation Comments Log, PK Mapping Specification, Clinical Data Transfer Plan, etc.

？ Build up eCRF and program online edit checks under supervision

？ Perform offline edit checks programming on various platforms under supervision (e.g. Medidata Rave, IBM Clinical, Mobile MD, etc.)

？ Perform Listings/Reports build-up on various platforms under supervision (e.g. SAS, BI platform, etc.)

？ Perform other modules/ functions build-up under supervision, including but not limited to Lab module, Report module and Coding module

？ Learn and understand IWRS modules build-up (e.g. Medidata Rave, IBM Clinical, Mobile MD, etc.)

？ Study Conduct

？ Perform Clinical/External data transfer under supervision

？ Perform eCRF modification under supervision

？ Perform online edit checks modification under supervision

？ Learn and understand URL management (e.g. Medidata Rave, IBM Clinical, Mobile MD, etc.)

？ Study Close out

？ Archive the important files from the system, including but not limited to Subject PDF, Audit Trial, database structure

任职资格:

？ Applied Knowledge & Skills

？ Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.) and Conferencing software like WebEx, ZOOM, Lync, etc.

？ Good communication skills in Mandarin and English (written and verbal)

？ Being familiar with at least two type of EDC system is preferred, including but not limited to Medidata Rave, IBM Clinical, and Mobile MD, etc.

？ Being familiar with SAS/SQL and basic JavaScript/VB/C# is preferred.

？ Minimum Qualifications

？ Bachelor or above

？ Major in Biology/Medical/Computer science are preferred

？ 2 years or above Industry Experience

康德弘翼（WuXi Clinical），是药明康德（WuXi AppTec）的一家全资子公司。始终致力为全球客户提供全方位的临床研究服务，包括药品、生物制品、医疗器械、体外诊断试剂等医药产品。从I期临床研究到最终申报注册，通过严格的质量控制体系和专业团队的丰富经验，帮助创新性，突破性医药产品尽快上市和造福患者。

康德弘翼立足中国，面向世界，以上海总部为中心，辐射全球制药公司、生物技术公司以及医疗器械公司。目前，公司实行中美联合运营，人员规模达850人，覆盖中美两地，全国30多个主要城市，在上海、北京、广州、武汉、成都、长沙、西安、沈阳和美国奥斯汀、圣地亚哥10个城市均设有办公室。公司团队与各研究中心建立了良好的合作关系，始终保持着紧密的业务交流，保证了项目能高效、高质地完成。

随着业务能力的不断提升，我们已将业务范围成功扩展到美国、欧盟和亚太地区的部分国家。2018年7月，药明康德成功收购位于德克萨斯州的一家美国临床研究机构并实现中美联合运营，2019年5月，再一次收购了位于圣地亚哥的临床研究服务公司Pharmapace，这让WuXi Clinical的规模再一次得到扩大，进一步完善和增强了我们全球一体化研发服务平台的综合实力，帮助全球创新合作伙伴更好、更快地开发医药产品。