Under the direction of the Director/Associate Director/ Manager, the Lead 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.
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.
9. Able to work independently, under pressure and change environment with flexibility.
Job: Clinical Data Management Job Title:Sr. Spclst, Clinical Data Mgmt
Primary Location: APAC-CN-11-Chaoyang
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
Job Segment: Developer, Programmer, Warehouse, Computer Science, Data Management, Technology, Manufacturing, Data