北京 [切换城市] 北京招聘

Clinical Trial Document Management Specialist (职位编号:235966BR)

爱尔康(中国)眼科产品有限公司 Alcon (China) Ophthalmic Product Co., Ltd.

  • 公司规模:10000人以上
  • 公司性质:外资(欧美)
  • 公司行业:医疗设备/器械

职位信息

  • 发布日期:2019-10-24
  • 工作地点:北京-朝阳区
  • 招聘人数:若干人
  • 工作经验:2年经验
  • 学历要求:招若干人
  • 语言要求:不限
  • 职位月薪:0.6-1.2万/月
  • 职位类别:其他

职位描述

Coordinates delivery, collection, and review of trial documents to and from investigator sites and the GCSM organization and ensures clinical site documentation is done in accordance with Alcon Standard Operating Procedures (SOPs), Good Clinical Practice (ICH-GCP), Good Business Practices and applicable regulatory requirements.

1. Coordinates delivery and collection of trial documents to and from investigator sites/GCSMs; including facilitating IRB/IEC submissions.

2. Ensures accuracy and quality documents included in the site initiation packets.

3. Enters and maintains site information and document tracking in current clinical systems.

4. Ensures trial documentation is well organized, filed appropriately, and is available and current for the study team.

5. May specialize in preparation of SIP, budgets/contracts, or in other specialized functions as needed.

6. Follows applicable work processes, SOPs, communication plans, etc.

7. Ensures timely elevation of issues with sites related to preparation/collection of trial documents, initiation packets, site budgets and contracts, or other relevant documentation.

8. May provide documents to other GC&RA functions as needed.

9. Works under direction of the lead/manager.

Work may be reviewed for soundess of judgment and overall adequacy and accuracy.


Education:

? University degree in life sciences Languages:

? English and other major languages preferred

Experience/Professional Requirement:

? Minimum of 1-2 years of applicable experience within clinical research and/or business administration

? Knowledge of applicable guidelines, including GCP guidelines, ICH and FDA   regulations     

职能类别:其他

公司介绍

爱尔康(中国)







作为全球眼科领域的领导者,爱尔康的使命是通过创新型产品,提高视觉质量,提高生活品质。这个使命意味着爱尔康22000多名员工为“保护、恢复和提高视力”的目标进行着不懈的努力与奋斗,使散光治疗,青光眼治疗,近视眼激光视力恢复矫正等等技术得到更好,更全面的普及,努力改善更多人的视力健康。
 
诺华和爱尔康合并后,爱尔康、视康和诺华眼科的优势融合到同一眼科保健业务,爱尔康已成为诺华集团第二大业务部门。公司合并带来的整合资源和业务覆盖的优势,爱尔康现在180个国家销售全线的眼科保健产品,包括手术产品、药品和视力保健产品,并在75个国家拥有分公司。
 
从一个孩子为矫正近视眼配的第一副隐形眼镜,到她的祖父母为治疗白内障而做的人工晶体植入,爱尔康的创新产品帮助各个年龄段的患者更清晰地看到世界。爱尔康的产品与高科技可用于解决诸多领域里日益增长的临床问题,例如白内障、青光眼、视网膜疾病、屈光不正、眼部过敏、眼部干涩、感染和发炎以及许多其他眼部护理需求。
 
在全球范围内,爱尔康有近2000名员工致力于研发工作,以满足世界上最迫切的眼部护理需求。同时,我们的业务也延伸到专业教育领域并在整个行业内处于领先水平。

联系方式

  • 公司地址:地址:span麦子店西路3号新恒基大厦12层