申请人
默沙东制药北京研发中心 招聘临床数据库开发工程师
于 默沙东制药北京研发中心 in 北京
Mapping Programmer/Senior Mapping Programmer
Department: MRL
Report to: Associate Director
Locations: Beijing, China
Position Overview – Basic Functions & Responsibility
Under the direction of the Associate Director/Manager, the Mapping Programmer support for the set-up and mapping, testing, and modification of programs to flow data from the collection source to the Clinical Data Repository. Demonstrates a working knowledge of CDISC standards (SDTM, ODM) and ETL tools to transfer data in support of clinical research. Primary customers are Global Data Management Services, Global Safety, Scientific Programming, and Clinical Research. Provides expertise for the processes and tools utilized by the Mapping Staff. Supports the documentation for SDLC including reporting and documenting testing results. All in compliance with Merck Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
Primary Activities
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:
75% 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.
20% Perform ongoing support for data flow. Change Requests and Incident Reports are fully documented, signed off, tracked, and reported to upper management.
5% Participate in process improvement initiatives, departmental meetings, and special projects.
Requirements:
Education:
· Bachelor’s degree in computer science or equivalent educational exposure to software design and development theory, techniques, testing methodologies, and software documentation.
Knowledge and Skills:
· At least 1 year to 2 years’ experience in
CDISC Standards, (SDTM, CDASH, Define.xml)
SQL, PL-SQL, XML, Java
ELT tools, preferably Contivo
· Expected to have a strong technical proficiency in a Clinical Data Management System. Particularly Inform, Data Loading, Data Transformations.
· Solid knowledge of MS Windows/Office software and exposure to web based applications.
· Working knowledge of System Development Lifecycle Management / system validation knowledge
· Ability to establish and maintain good working relationships with different functional areas.
· Strong sense of urgency and customer focus.
· Strong organizational and problem-solving skills.
· Desire and ability to learn new processes and technologies
· Ability to multi-task, work independently, and good communication skills
· Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.
How to Apply:
Please directly send your resume to Lin, Jing ( jing.lin1@merck.com)