Job Title: Clinical Data Analyst
Development of clinical data standards (operational, Clinical Data Interchange Standards Consortium (CDISC), Clinical data Acquisition standard Harmonization (CDASH), Study data Tabulation Model (SDTM) and Analysis data Model (ADAM) aligned with regulatory requirements for submission also includes SDTM mapping specifications and SDTM annotated CRF. Experience with Clinical tools like Medidata Rave (To design and create the metadata), MDR (MetaData Repository), Pinnacle 21 (to validate the Trial design Domain) and SAS to integrate all pieces of trial data (both CRF and non CRF data) to make submission ready package for the regulatory authorities.
BS in Information Technology and 60 months of experience in offered position or related field. Employer will accept applicants who have other suitable combos of educ, training or exp.