盖博医药信息咨询服务（上海）有限公司 诚聘 Senior Data Manager

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- a( V1 L8 x5 H7 ?6 ~; |7 d Position: Senior Data Manager

Position Description:
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The Senior Data Manager coordinates all data management tasks for a given clinical study or studies involving investigational or non-investigational drugs, biologics and devices and acts as the primary point of contact for all data management activities for a given clinical study or studies.

Responsibilities Include:

" U$ H; g$ \1 `9 G9 ~, e3 n• Reviews and understands study protocol and assures consistency internal to the protocol and the goals of the study/program
, B9 m5 r% U8 O• Designs Case Report Forms (CRF) and coordinates review by project team
5 Q. ~9 C" H/ p' y: [" s' V% S# E• Communicates with client regarding CRF design issues
• Coordinates the printing and shipping of CRFs
/ x' B6 I1 P7 M5 v# a: v• Develops Data Management Plan (Edit Check Specifications, CRF completion guidelines, and Self Evident Correction Guidelines, etc) for each assigned clinical study
• Coordinates the review of clinical trial data, identifies erroneous, missing, incomplete, or implausible data and writes queries
4 n' A. w0 f. g• Understands the fundamental needs for and uses of relational databases and can work with IT Applications to ensure proper clinical database design
8 I6 a! V; ]3 ]+ J% M6 V" ~0 m• Troubleshoots system problems, resolve related issues, and recommend appropriate modifications
• Understands the fundamentals of management of central laboratory data and other types of electronic data
• Ensures that all external data is imported into the database and define quality acceptance criteria for electronic data
6 R5 y! |; z' n7 X• Oversees coding of adverse events and medications
• Assigns tasks to data reviewers
• Coordinates with Project Coordinator to assure timely submission of CRFs and queries from sites
• Represents Data Management at project team meetings and provides updates to project team on status of CDM tasks
7 [4 f4 U) a1 ]# R• Communicates with Project Manager and Project Coordinator regarding project team and/or client issues
• Ensures that all preparatory steps to lock a clinical database are accomplished and database is locked successfully and within the timelines
• Ensures adherence to all timelines associated with data management
. O' B6 Q& N2 c3 I6 N; A$ \• Assures that the data management needs of project(s) are met, reporting all areas of concern to the Manager of CDM Department to assure timely and appropriate resolution of clinical team and/or client issues
• Assures that all aspects of data management are performed in accordance with client requirements and applicable corporate SOPs/WPDs, Federal Law, Guidelines and ICH standards, as appropriate
• Supervises, coaches, and develops staff
; X) r8 e) O& O  l% k  `( w; `0 f• Ensures that required training for directly supervised staff members is identified, provided in within a reasonable timeframe, and is current
• Other relevant duties assigned for which the incumbent is qualified

1 d2 L( T: u) ?9 J Requirements:

• Bachelor’s degree in medical or healthcare-related science, MS or above welcomed
• An advanced scientific degree (M.S., PhD.) or clinical certification (R.N., M.D.) is desired
* l- V$ t5 W( M; c3 w& e• At least three years of clinical data management experience in a pharmaceutical company or CRO or equivalent education and experience
! |# [6 q" W" G# M/ p6 a9 f3 H+ g• Oracle Clinical database experience preferred
• Supervisory experience preferred
- V% b  {: \0 c• Demonstrated strong skills in the management and resolution of data-related issues
" u& t0 P' L( g0 u$ W• Demonstrated strong communication and analytical skills
* Q" I& n) D! v$ [: H; l5 E3 @• Demonstrated well organizational skill and able to prioritize multiple tasks
6 w+ o: U1 S5 e: Q: P• Be able to manage multiple projects, as necessary
) n1 s$ I, j0 g: G/ |• Strong team-building skills and the ability to work successfully in a team environment
• Knowledgeable about the Federal regulations and requirements governing the conduct of drug, biologic and device studies including, but not limited to, GCP and ICH requirements
• Experienced in developing and leading effective presentations in public settings
• Demonstrated verbal and written communication skills in both Chinese and English.
• Demonstrated computer skills including MS Office and Internet usage.
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) n  @0 p9 g9 K) n  U盖博医药信息咨询服务（上海）有限公司

) Q/ F4 ^: b8 v$ l. U! dGlobal Medical Consulting Services (Shanghai) Co., Ltd. (GMCS) is a wholly owned subsidiary of US-based Global Research Services, LLC (GRS). GRS has offices also in Canada, Germany, Poland, Britain, Brazil and India. GMCS is a leader in the management of clinical research programs for the pharmaceutical, biotech, and medical device communities. The company provides a full range of consulting and clinical trial management services that include protocol design, project management, data management, clinical site monitoring, biostatistical analysis, and medical report writing.
0 B. ~: O) a9 n. S& n*盖博医药信息咨询服务（上海）有限公司是一家国际性临床研究公司（CRO），总公司盖博研究服务有限公司（GRS）位于美国马里兰州罗克维尔市，并在加拿大、德国、波兰、 英国、巴西、印度以及中国设有分公司。作为GRS在中国注册全资子公司，盖博医药坐落于上海南京东路步行街黄浦商业圈。自1998年运营以来（前身为美国美迪范国际公司），盖博医药一直为全球的药厂、生物科技企业和医疗器械研发公司提供世界一流的临床试验及管理服务，包括临床管理、药物安全性管理、数据管理及生物统计支持等。
( z2 {* `) y& a7 S" o+ o*我们在世界各地与经验丰富的临床研究者及研究基地建立了广泛的联系网络，使得盖博能够为客户提供多种临床研究方案。
*我们始终坚持高品质服务，在中国的本土团队也同样遵循ICH、GCP、FDA的工作标准，严格执行总公司的操作流程及客户所要求的操作规范。通过盖博在世界各地的分支机构的密切合作，有效保证了公司全球信息网络、信息基础架构、应用程序、通讯线路和备份系统符合FDA 21CFR11的要求。盖博医药曾多次接受并通过了诸多国际大药厂的审核，并有幸成为第一批通过中国国家食品药品监督管理局核查并获得高品质赞誉的临床研究合同委托公司（CRO）。
6 s9 v9 S- T8 O' G*多年的积累，多年的奋斗，成就了今日盖博的辉煌和底蕴。总公司正在进一步加大在中国的投资和致力于中国团队的建设，盖博医药的目标是要成为员工和客户的最佳选择。
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; c. R5 M( R" W% a) G**选择盖博，成就你我……**         
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*丰厚的薪资待遇和假期
. \4 F) Z$ h$ o0 X1.按国家规定缴纳四金；100%医疗保险报销制度；额外商业保险。
2. 薪资待遇在行业绝对领先。
3.第一年即享有17天年休假（法定节假日除外），之后每年相应增加1天，可累计不作废。
         
*GLOBAL项目和平台优势
; I8 Q8 m4 o: w) H: p" n- T- Y1. 所有项目均为FDA和其它global项目，零距离接触国际最领先的临床试验标准；
2. 数据管理和统计分析均有标准化的操作平台，该平台在行业内绝对处于领先地位；
3. 数据管理使用最先进的Oracle Clinical数据管理系统；统计分析采用CDISC标准和标准的SAS Macro统一出表；
; U0 W  L# \8 s& x7 i* W: @3 K4.  选择盖博，您不仅选择了一份高薪工作，更重要的是选择了走向职业成功的道路。

*人性化的管理，健全的职业培养和升迁机制
1. 入职后专门培训机制：每位新入职的员工均有专门培训，包括IT和专业培训，并且Team Leader带领您成长。根据业务发展需要，安排出国培训或者参加国际性会议的机会；
2. 学习与发展计划: 针对个别员工的专业及兴趣，设计个人职业生涯规划和培养机制；
" j& J0 I  _' J. @$ h+ Z3. 顺畅的升迁机制，提供走向成功的职业发展。

*优质的工作环境和便利的交通
8 q0 X% e4 T! F- H3 J8 j1. 和谐的企业文化：公司致力营造相互尊重，相互支持，共同发展的良好工作氛围，同时充分尊重员工的工作生活的平衡；
2. 繁华的办公地点：地处南京东路步行街宏伊国际广场12楼，步行到外滩仅需5分钟，豫园10分钟；全国金融中心就在您的身边，最繁华的南京东路步行街就在您的脚下；
' {1 W& R% o' ?! Q4 U; D; f3. 优质的办公环境：办公室即可尽览黄浦江、东方明珠、陆家嘴，让您体验现代文明，感受上海瞬息变化；
4. 便利的交通：地铁2号线南京东路站直接上楼，10号线马上开通，1、8号线人民广场仅一站换乘。

* d7 L) {' f9 P. a" U$ V* `*_*有意者请发送简历至
1 ?' X. t# o7 z/ p$ k  x7 K电话：+86（21）3366-5188～90
应聘Email：shanghaihr@grs-cro.com
. G! ^2 R2 I5 `* e6 b! B& y$ Z地址：上海市黄浦区南京东路299号宏伊国际广场1201室，200001
总公司网址： www.grs-cro.com
上海分公司网址：www.grs-cro.com.cn

这个本科应该可以做

Bachelor’s degree in medical or healthcare-related science, MS or above welcomed

有医学背景比较好。

这几个英文太帅呆了。。一个没看懂。。