Manager, Clinical Data and Reporting Standards - SDTM Programming (Hybrid)
abbvie · Irvine, CA, us
- Posted
- 47 days ago
- Last confirmed live
- 1 day ago
What this role involves
The Manager, Clinical Data and Reporting Standards (CDARS) leads the development of data and reporting standards for clinical trials, ensuring compliance with CDISC standards. Responsibilities include SDTM programming, overseeing dataset creation for regulatory submissions, and collaborating with cross-functional teams. The role requires experience with SDTM and leading standards development, with a preference for CDASH and ADaM knowledge.
Skills this posting asks for
- sdtm
- adam
- cdash
- cdisc
- clinical data management
- regulatory submissions
- fda
- pmda
- define.xml
- annotated crf
- clinical study data reviewer's guide
- tlf
- analysis results metadata
Requirements
- 8 years of experience
- Level: manager
- Remote policy: hybrid
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Approve this role and the application is completed for you, including a résumé tailored to it. You get a confirmation when it lands, and a credit is only spent when a submission is confirmed.
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