临床数据映射程序员
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8K-10K元/月
  • 全职
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  • 北京
  • |
  • 2 人
  • |
  • 不限工作经验
  • |
  • 硕士研究生及以上
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默沙东(中国)投资有限公司 招聘经理

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职位描述

  • 五险一金
  • 弹性工作制
  • 周末双休
  • 免费班车
  • 试用期全薪
  • 内部培训
  • 带薪年假
  • 免费体检
  • 接受应届生
  • 制药/生物工程行业
  • 临床数据分析员
招聘人数:2 人

                    职位职责:

                    
职位描述:
该职位的主要职责是依据MSD的相关SOP以及ICH-GCP的要求完成对临床试验原始采集数据到CDISC SDTM标准化数据结构的映射转换相关工作。

主要任务包括:
1.与临床项目团队合作,生成项目SDTM数据映射规范文档;
2.根据SOP设计,构建,维护,测试项目SDTM数据表格样式,保证临床数据的正确映射转换;
3.协调并处理临床数据映射过程中遇到的问题,保证临床试验数据的实时映射转换;
4.给予临床数据映射流及时支持,包括临床试验变更请求的签字跟踪归档和向上级管理部门报告;
5.灵活运用计算机技术,对工作流程进行优化,通过工具开发对数据映射,实时转换进行验证,监测,确保数据质量;
6.参与各种部门活动,提供对工作流程改善和特殊项目的支持;
主要合作对象: 全球临床管理团队,临床研究团队。

职位要求:
教育背景:
1.本科以上学历, 计算机专业,数学、药学、医学、生物科学及卫生保健相关学科。
知识及技能要求:
1.较强的沟通技巧(口语及书面);
2.较强的组织协调能力及解决问题的能力;
3.能够与不同职能部门建立和维护良好工作关系;
4.具有抗压能力,能处理多变的工作环境,并能独立完成多项工作;
5.有较强的时间观念和客户至上的意识;
6.对新流程和新技术有学习兴趣和能力;

优先选择:
1.具备CDISC SDTM相关知识,有临床数据SDTM映射经验;
2.熟悉临床数据系统,具有临床数据库设计开发/临床报表开发等相关经验(OC/Inform/Rave);
3.具备系统全面的临床研究开发流程的相关知识,有临床数据管理相关经验;
4.具备数据库结构及相关工具(用于管理,抽取以及汇报数据)的知识;
5.具备编程知识和经验(SQL,PL-SQL,Java, Python, Perl, C/C++, C#, XML);

Responsibility:
Under the direction of the Director/Associate Director/ Manager, the Mapping Programmer II/Senior Mapping Programmer provides Subject Matter Expertise for the processes and tools utilized by the Mapping Staff.  Understands the tools and technology utilized in support of data flow.  Supports CLMM and E2E. Supports the documentation for SDLC including writing test scripts, reporting and documenting testing results.  All in compliance with MSD Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
Primary activities include, but are not limited to:
Assumes the responsibilities for all data mapping deliverables including SDTM structure set-up and transformation maps to support multiple clinical programs. Coordinates and participates in the following activities:
30% Design, build, maintain, test, and document data mapping specifications based on clinical database structures establish by Global Clinical Data Management and Clinical Research.  Mapping specifications must meet SDTM structure requirements utilizing CLMM and E2E visibility tools to ensure quality and timeliness of data flow to the Clinical Data Repository.  Review the technical feasibility needs for transformations and technically implements them in support of the Business Rules required for SDTM compliance and the Clinical Data Repository in support of Analysis and Reporting performed by Scientific Programming of study team proposed reports. Work effectively among RaM Mapping team to communicate issues and ideas to improve the business.
30% Support the standard library development for data mapping to the clinical data repository including support of the business rules utilized for Analysis and Reporting and transformations to verify data transfer between and across the various databases among data collection, reporting, and the data repository. This includes the maintenance of the maplets in the Contivo library as well as the transformations for the E2E visibility tool.
15% Under proper change management, responsible for change requests and incidence correction into clinical database. Ongoing support in a dynamic and matrix organization.
25% Participate in extra activities including, but not limited to, study improvement task forces, automations, initiatives, testing of new systems, and ongoing training and mentoring.

Requirements
Education:
1.At least B.A. or B.S. degree, preferably in mathematics, science, a health care related discipline, or computer science.

Knowledge and Skills:
1.4+ years’ experience with
a.CDISC Standards, (SDTM, CDASH, Define.xml)
b.SQL, PL-SQL, XML, Java.
c.ELT tools, preferably Contivo.
2.Solid knowledge of Clinical Database Development/Reporting tools (e.g., InForm, Data Loading, SQL, PL-SQL, Java)
3.Solid knowledge of System Development Lifecycle Management / system validation knowledge
4.Solid knowledge of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.
5.Solid knowledge of database structures and available tools to manage, extract, report and warehouse data.
6.Strong communication skills (oral and written) with the ability to communicate with both the technical and business areas.
7.Strong organizational and problem-solving skills.
8.Ability to work cross functionally and as part of a team.
Able to work independently, under pressure and change environment with flexibility.

工作地点

北京 望京来广营容达路默沙东研发中心 收起地图