Full time, contract
Description
Experience; 2+Duration; 6MonthsRoles and Responsibilities Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications datasets SDRG Annotated CRF) for Client studies Serve as Study SDTM Programming lead for all regulatory submissions Expertise in Client SDTM automation tools macros and using them for SDTM programming Strong understanding of Client EDC SDTM metadata and metadata driven Review the Study EDC specification and ensure all collected study data (including external) is mapped appropriately in target SDTM model Design the SDTM specification as per the CDISC SDTM IG and ensure they meet downstream ADaM and Reporting requirements Annotate CRFs and Review annotated CRFs in accordance with Client guidelines and appropriate metadata to reflect tabulation datasets Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and Client Quality tools Collaborate with stakeholders and Study team members to manage study timelines and resolve issues Represent SDTM Programming function in Study team meetings as well as cross-functional working groups and process improvement activities Provide subject matter expertise in defining the mapping relationships between source EDC and target SDTM domains Support
