长沙 [切换城市] 长沙招聘长沙生物/制药/医疗器械招聘长沙生物工程/生物制药招聘

Registry Quality Control Associate临床注册质量管理

上海康德弘翼医学临床研究有限公司

  • 公司规模:500-1000人
  • 公司性质:合资
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2016-09-11
  • 工作地点:武汉-洪山区
  • 招聘人数:若干人
  • 学历要求:本科
  • 语言要求:英语 精通
  • 职位月薪:3500-5500/月
  • 职位类别:医药技术研发人员  生物工程/生物制药

职位描述

职位描述:
Responsibilities:
Registry Quality Control Associate (RQCA) is responsible for ensuring the completeness and accuracy of Registry data in Clinical Trial Management System (CTMS) by performing Quality Control (QC) on data attributes entered in CTMS against the available source documents in TMF. Working responsibilities may include, but not limited to:
1. Run and review the Registry Quality Control reports or other logic checks throughout clinical study life cycle
2. Investigate logic check flags, utilizing system information as well as applicable study documentation
3. Review data attributes, identify and investigate any potential discrepancies, and then generate RQC Query Log
4. Work closely with the Registry Point-of-Contact (POC) from Study Team to resolve any identified quality issues
5. Conduct centralized data entry in CTMS

Qualifications:
1. Bachelor’s degree or above. Pharmacy or Medicine related preferred.
2. Good English verbal and written communication skills.
3. Ability to communicate effectively and appropriately.
4. Ability to organize tasks, manage time and make priorities.
5. Ability to attend to details and follow guidelines and procedures.
6. Ability to work independently and within a team, and demonstrated as a good team player.
7. Good computer skills with widely used software e.g. Microsoft office
8. History of achievement in a customer service role with demonstration of meeting customer needs and concerns preferred.
9. Experience with Clinical Trial related work preferred.
10. Experience in management of medical/clinical study records and documentation preferred.
11. Experience/knowledge of ICH/GCP documentation requirements preferred.
12. Experience with web based data management systems preferred.
13. Experience with database utilization preferred.

职能类别: 医药技术研发人员 生物工程/生物制药

关键字: RQC 注册质量管理 带薪年假 周末双休 人才推荐奖 Registry Quality Control

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公司介绍

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。

联系方式

  • 公司地址:上海市黄浦区淡水路299号SOHO复兴广场A幢801室 (邮编:200020)