The Mapping Programmer plays a vital role in supporting the development of Data Management Workbench (DMW) and Electronic Data Capture (EDC) systems for both standard and pipeline projects. This role includes designing, modifying, and documenting clinical databases and their supporting systems to effectively support clinical trials. Additionally, the Mapping Programmer will assist with a variety of data flow mapping activities, ensuring that all processes adhere to company 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 DMW 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 DMW in the PDAMNG 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.
Master's degree in a relevant field such as Medicine, Computer Science, Big Data, or a related discipline.
Knowledge and Skills:
Clinical Data Cleaning, Data Analysis, Database Development, Data Processing, Data Validation, Electronic Data Capture (EDC), PL/SQL (Programming Language)
Database Structures, R Statistics, Standard Operating Procedure (SOP)
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Regular
No relocation
No
No Travel Required
Not Applicable
Not Indicated
No
NA
12/31/2026
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