500强外资医药公司-Senior Study Data Manager
北京外企德科人力资源服务上海有限公司
- 公司规模:10000人以上
- 公司性质:合资(欧美)
- 公司行业:专业服务(咨询、人力资源、财会)
职位信息
- 发布日期:2016-10-16
- 工作地点:北京-朝阳区
- 招聘人数:10人
- 职位月薪:15000-30000/月
- 职位类别:临床数据分析员 临床研究员
职位描述
职位描述:
Duties and Responsibilities
1. Primary contact between Trial Operation and clinical study teams. Liaises directly with internal customers (Clinical, Biostatistics, Quality Assurance, Regulatory Affairs) and external customers (affiliates, CROs, clinical research units) to cover all aspects of data management for assigned studies. Negotiates responsibilities and timelines. Ensures departmental companion groups (i.e., Coding, TIM, Reporting Factory) are consulted appropriately on study decisions. Implements and oversees processes and coordinates activities in conjunction with the study team and Team Leader. Proposes solutions for data management issues that arise during the conduct of a study.
2. In charge of the development of CRFs, Data Management Plan, Data Validation Plan, Data Review Report as per company standards. Assures that data management standards are followed for the studies in charge.
3. Coordinates DM study teams (Clinical Data Coordinators, contractors) assigned to support studies.
4. Continually evaluates DM processes and applications for improvements. Participates in working groups to develop and implement new applications and procedures. Maintains knowledge of current regulations and technologies related to the data management function.
5. Participates in the implementation of department initiatives.
6. Assume the mentor role for junior staff and oversee the quality of data management activities for designated mentee.
Knowledge and Skill Requirements
Knowledge &Skills:
Solid Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical) and understanding of database/programming concepts. Expert in the use of Data Management applications and database/file structures; able to identify discrepencies by using query langurages, such as SQL; able to acquire and apply new technical skills. Knowledge of industry standards and practices. Understands the clinical development process. Communicates effectively with study teams and departmental associates. Establishes rapport and collaborates with others both inside and outside the company; builds constructive and effective relationships; demonstrates flexibility through effective negotiations, can be direct yet diplomatic. Anticipates problems, issues, and delays, and proactively works to minimize the impact; follows through on all tasks and ensures high quality results. Consistently meets deadlines according to accepted levels of quality, paying attention to details. Learns quickly when facing new problems; uses rigorous, objective logic and methods to solve difficult problems with effective solutions; follows implementation plans through to completion. Sets clear assignments as well as clear objectives and measures; monitors process, progress and results. Oral and written English communication skills.
Education and experience required:
Bachelor degree or above, preferably in a life science or mathematics-related area (e.g., computer sciencecs) and equivalent experience (at least 4 years) in clinical data management.
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Duties and Responsibilities
1. Primary contact between Trial Operation and clinical study teams. Liaises directly with internal customers (Clinical, Biostatistics, Quality Assurance, Regulatory Affairs) and external customers (affiliates, CROs, clinical research units) to cover all aspects of data management for assigned studies. Negotiates responsibilities and timelines. Ensures departmental companion groups (i.e., Coding, TIM, Reporting Factory) are consulted appropriately on study decisions. Implements and oversees processes and coordinates activities in conjunction with the study team and Team Leader. Proposes solutions for data management issues that arise during the conduct of a study.
2. In charge of the development of CRFs, Data Management Plan, Data Validation Plan, Data Review Report as per company standards. Assures that data management standards are followed for the studies in charge.
3. Coordinates DM study teams (Clinical Data Coordinators, contractors) assigned to support studies.
4. Continually evaluates DM processes and applications for improvements. Participates in working groups to develop and implement new applications and procedures. Maintains knowledge of current regulations and technologies related to the data management function.
5. Participates in the implementation of department initiatives.
6. Assume the mentor role for junior staff and oversee the quality of data management activities for designated mentee.
Knowledge and Skill Requirements
Knowledge &Skills:
Solid Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical) and understanding of database/programming concepts. Expert in the use of Data Management applications and database/file structures; able to identify discrepencies by using query langurages, such as SQL; able to acquire and apply new technical skills. Knowledge of industry standards and practices. Understands the clinical development process. Communicates effectively with study teams and departmental associates. Establishes rapport and collaborates with others both inside and outside the company; builds constructive and effective relationships; demonstrates flexibility through effective negotiations, can be direct yet diplomatic. Anticipates problems, issues, and delays, and proactively works to minimize the impact; follows through on all tasks and ensures high quality results. Consistently meets deadlines according to accepted levels of quality, paying attention to details. Learns quickly when facing new problems; uses rigorous, objective logic and methods to solve difficult problems with effective solutions; follows implementation plans through to completion. Sets clear assignments as well as clear objectives and measures; monitors process, progress and results. Oral and written English communication skills.
Education and experience required:
Bachelor degree or above, preferably in a life science or mathematics-related area (e.g., computer sciencecs) and equivalent experience (at least 4 years) in clinical data management.
职能类别: 临床数据分析员 临床研究员
公司介绍
北京外企德科人力资源服务上海有限公司(简称 FESCO Adecco 外企德科)是中国人力资源服务行业具竞争力和品牌价值的FESCO与全球人力资源服务行业领航者Adecco成立的一家中外合资人力资源服务企业,为企业及个人提供业务外包、人事服务、招聘猎头和员工福利等相关人力资源解决方案。
成立于1979年,FESCO拥有悠久的人力资源专业化服务历史、丰富的市场经验以及完备的服务资质,是中国人力资源服务行业的领跑者,Adecco则是全球人力资源行业的巨头,服务网络遍布全球60多个国家和地区。FESCO Adecco成立后,双方通过优势互补,整合了客户资源,依托全球化的资源和服务平台,融合本土网络优势,扩大了业务范围,为客户提供全方位的业务流程外包(BPO)、财务外包与薪酬管理、人事委托/人事派遣、全球化派遣、人才招聘/RPO相关服务、健康福利与弹性福利等人力资源解决方案。合资后的FESCO Adecco飞速发展,并且在浙江、重庆、深圳、苏州设立了分支机构。目前,FESCO Adecco在中国每天服务达100万名员工,服务客户近12,000家。
FESCO Adecco致力于成为***的人力资源全面解决方案提供商,成为客户最值得信赖的人力资源合作伙伴。为客户打开通向国际市场及创新型人力资源服务模式的大门,推动中国乃至全球的人力资源外包产业的健康发展。
成立于1979年,FESCO拥有悠久的人力资源专业化服务历史、丰富的市场经验以及完备的服务资质,是中国人力资源服务行业的领跑者,Adecco则是全球人力资源行业的巨头,服务网络遍布全球60多个国家和地区。FESCO Adecco成立后,双方通过优势互补,整合了客户资源,依托全球化的资源和服务平台,融合本土网络优势,扩大了业务范围,为客户提供全方位的业务流程外包(BPO)、财务外包与薪酬管理、人事委托/人事派遣、全球化派遣、人才招聘/RPO相关服务、健康福利与弹性福利等人力资源解决方案。合资后的FESCO Adecco飞速发展,并且在浙江、重庆、深圳、苏州设立了分支机构。目前,FESCO Adecco在中国每天服务达100万名员工,服务客户近12,000家。
FESCO Adecco致力于成为***的人力资源全面解决方案提供商,成为客户最值得信赖的人力资源合作伙伴。为客户打开通向国际市场及创新型人力资源服务模式的大门,推动中国乃至全球的人力资源外包产业的健康发展。
联系方式
- Email:recruitment@circassia.com
- 公司地址:天目西路128号嘉里不夜城企业中心***座19楼