Clinical Data Management Specialist
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：2019-01-17
- 工作地点：上海-闵行区
- 招聘人数：1人
- 工作经验：3-4年经验
- 学历要求：本科
- 职位月薪：1.5-2万/月
- 职位类别：生物工程/生物制药
职位描述
Job Summary :
1. Performs data management activities for both clinical studies and development projects as assigned. Ensures the
delivery of complete, accurate data that is ready for analysis and regulatory submission.
2. Defines and applies study-specific data management workflow. Interacts with internal and external teams to define
study-specific data requirements.
3. Participates in database planning and user acceptance testing. Organizes and facilitates data entry and data
management tasks to ensure timely study deliverables. May have primary ownership of one or more projects.
4. Ensures DM activities in compliance with the company SOPs, Policies, Directives, Divisional standards, Declaration
of Helsinki, Industry standards, relevant GCPs, both CNMPA and/or international requirements and/or best
practices.
Main Tasks & Responsibilities
1. Functions as Lead Data Manager for assigned projects, acting as the primary point of contact for clinical data
management issues for assigned components. The responsibilities cover both internal and outsourcing studies.
2. Uses knowledge of clinical data management to define data flow for assigned projects. Identifies and implements
updates to study-specific processes as needed.
3. Creates or oversees creation of data management documentation for assigned projects, including the Case Report
Form (CRF), Data Management Plan (DMP), and clinical database specifications. Maintains robust documentation
to ensure and/or document regulatory compliance at all times. Identifies and implements updates to documentation
as needed.
4. Uses knowledge of database management to define clinical database requirements. Performs user acceptance testing
of clinical database and edit checks.
5. Provides study-specific data entry training to data entry staff. Oversees data entry staff to ensure data quality.
6. Performs clinical study data review as required by the DMP. Identifies incomplete, erroneous, and/or discrepant data
and uses discretion to resolve issues. Identifies and manages data trends.
JD (Sr.) Clinical Data Management Specialist_Version1.0/Date10Jan2019 Page 2 of 3
7. Manages data discrepancy process to ensure discrepancies are generated and resolved in a satisfactory and timely
manner as part of the study team. Uses professional judgment to escalate issues appropriately.
8. Updates clinical database based on queries, data clarification forms, discrepancy management guidelines, and
performs other database changes as necessary for a study.
9. Maintains proficiency in use and analysis of clinical database system(s) and overall awareness of clinical data
management practices.
10. To be window person of MRA data management to other functions, handle inquiries and feedback; provide active
and strong technical supports to internal or external as needed. Keep smoothly interaction with global DM team.
11. Develop and maintain a good working relationship with other functions, to support the clinical projects.
12. Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche
Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection
13. Performs other duties as assigned.
Basic Requirements of the Job
Education& Qualifications
1. At least Bachelor degree in medical science degree, preferably in preventive medicine, medical laboratory,
pharmacology, biological sciences, or health care related discipline.
2. Familiarity with regulatory and ICH-GCP guidelines applicable to data management.
3. Proficiency in both spoken and written English.
4. Good command of MS office software application. Ability to work with relevant computer software, including
spreadsheets, word-processing and database packages (e.g., Microsoft Excel, Word and Access).
如，Microsoft Excel, Word 和Access）。
5. Ability to work with clinical database software (e.g., Medrio, Oracle Clinical, RAVE, Inform, etc.).
6. Comprehensive understanding of the clinical study process.
Experience
1. At least 3 years of clinical data management experience with Global pharmaceutical companies, Medical Device
companies, Clinical Research Organization, Business Process Outsourcing companies.
2. Clinical database setting up SAS programming and data management procedure development experience is preferred.
职能类别： 生物工程/生物制药
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