长沙招聘

Job Summary 职位概述:

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.

对所分配的临床研究和开发项目进行数据管理活动。确保交付完整、准确的数据，以便进行数据分析和用

于向监管部门递交。

2. Defines and applies study-specific data management workflow. Interacts with internal and external teams to define

study-specific data requirements.

定义和应用临床研究特定的数据管理工作流程。与内部和外部团队进行交互，以定义临床研究特定的数据

需求。

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.

参与数据库计划和用户验收测试。组织和促进数据录入和数据管理任务，以确保及时的学习成果。可能拥

有一个或多个项目的主要所有权。

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.

确保数据管理活动符合公司SOP,政策，指令，标准，赫尔辛基宣言，行业标准，相关的GxPs, 以及

NMPA，国际药监部门的要求。

Main Tasks & Responsibilities 主要工作职责 :

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.

作为指定临床试验项目数据管理的主导者，在内部和外部供应商承接的项目中作为临床数据管理问题的主

要联络人。

2. Uses knowledge of clinical data management to define data flow for assigned projects. Identifies and implements

updates to study-specific processes as needed.

运用临床数据管理知识来定义已分配项目的数据流。根据需要识别和实施对研究特定的流程进行更新。

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.

生成已分配项目的数据管理文件，包括病例报告表（CRF）, 数据管理计划（DMP）和数据库规范。维护健

全的文档以确保文件的法规依从性。根据需要识别和实施对文档进行更新。

4. Uses knowledge of database management to define clinical database requirements. Performs user acceptance testing

of clinical database and edit checks.

运用数据库管理知识来定义临床数据库需求。对临床数据库进行用户验收测试和编辑检查。

5. Provides study-specific data entry training to data entry staff. Oversees data entry staff to ensure data quality.

提供项目特定的数据录入培训，监督管理数据录入的质量。

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.

依据DMP 进行临床试验数据的审核。识别不完整，错误和/或差异数据并判断解决数据问题。识别和管理

数据趋势。

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.

管理数据差异以确保差异符合要求及时解决。使用专业判断适当地升级报告数据问题。

8. Updates clinical database based on queries, data clarification forms, discrepancy management guidelines, and

performs other database changes as necessary for a study.

根据数据质疑、数据澄清表、差异管理指南更新临床数据库，并根据需要进行研究数据库其他相关变更。

9. Maintains proficiency in use and analysis of clinical database system(s) and overall awareness of clinical data

management practices.

保持熟练使用和分析临床数据库系统（s）和对临床数据管理的全面认识。

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.

作为数据管理职能窗口人，接受来自其它职能的咨询，积极主动反馈，为内外部各职能提供及时和有力的

专业支持。与全球数据管理团队保持流畅地沟通协作。

11. Develop and maintain a good working relationship with other functions, to support the clinical projects.

开拓并维护与其他职能的良好工作关系，以支持临床试验项目的顺利开展。

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

遵循罗氏所有合规要求，包括但不限于罗氏信息安全，罗氏商业中的行为，罗氏竞争法互动对话，罗氏安

全健康环境等，合法合理开展业务活动

13. Performs other duties as assigned.

其他交办的工作。

Basic Requirements of the Job 基本任职资格:

Education& Qualifications 教育背景与专业资格:

1. At least Bachelor degree in medical science degree, preferably in preventive medicine, medical laboratory,

pharmacology, biological sciences, or health care related discipline.

医学及生命科学相关专业本科及以上学历，预防医学、医学检验、药学、生物学优先。

2. Familiarity with regulatory and ICH-GCP guidelines applicable to data management.

熟悉法规及ICH-GCP 相关指南对于数据管理的要求。

3. Proficiency in both spoken and written English.

熟练掌握英语口语及书面表达。

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).

熟练使用微软办公软件应用程序。能够使用相关的计算机软件，包括电子表格，文字处理和数据库包（例

如，Microsoft Excel, Word 和Access）。

5. Ability to work with clinical database software (e.g., Medrio, Oracle Clinical, RAVE, Inform, etc.).

熟练使用临床数据库软件（例如, Medrio, Oracle Clinical, RAVE, Inform 等）。

6. Comprehensive understanding of the clinical study process.

全面了解临床试验过程。

Experience 工作经验:

1. At least 3 years of clinical data management experience with Global pharmaceutical companies, Medical Device

companies, Clinical Research Organization, Business Process Outsourcing companies.

至少3 年临床数据管理工作经验在全球制药企业，医疗器械企业、合同研究组或服务外包商。

2. Clinical database setting up SAS programming and data management procedure development experience is preferred.

有临床试验数据库, SAS 编程及数据管理流程建立经验者优先。

Health Conditions 身体状况:

According to the "Quality Management Regulations for Medical Device Management" and the "Regulations on

Quality Management of Pharmaceutical Products", health checks should be conducted at least once a year; if you have

infectious diseases or other diseases that may contaminate medical devices or drugs shall not be engaged in related

work.

根据《医疗器械经营质量管理规范》以及《药品经营质量管理规范》中的有关规定，应当至少每年进 行一

次健康检查；如患有传染病或者其他可能污染医疗器械或药品的疾病的，不得从事相关工作。

JD

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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。