SDTM Standards Engineer
SDTM SME - This individual will review existing standards and update them/make recommendations to map to new domains. Also, will participate in the Oncology Standards Steering committee and give feedback on new forms and updates to existing forms for Oncology data collection. This person will be the POC for all oncology specific standards questions.
- Provides technical and/or operational support in the delivery and application of industry clinical data standards within the statistical programming data flow (i.e., SDTM, DEFINE) for clinical studies, drug programs, and/or in support of drug application submissions.
- Implements standards that supports data standards strategies and processes in alignment with the vision developed by Client’s Data Standards Team
- Acts as SDTM SME in development of standards management strategy and ongoing development and maintenance of standards across Client’s portfolio (i.e., CRF to Submission, Drug Program level standards).
- Ensures synchronization of Data Collection Standards with SDTM Standards and applicable company tools/system requirements in collaboration with CRF/Non-CRF Data Collection and SDTM Standards SMEs.
- Identifies data inconsistencies with respect to data standards compliance and proposes solutions that support data review/efficiencies including ensuring robust master dataset specifications and correct interpretation of protocol, analysis and CDISC compliance requirements.
- Ensures study level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity.
- Works closely with Study leads/ Data Management on development of data standards to support data collection requirements; including but not limited to specification of Data transfer agreements (DTAs) in alignment with downstream SDTM and other dataset formats, CRF Standard data collection elements, and external data oversight/strategies to ensure downstream compliance for submission.
- Support in developing, managing and maintaining libraries of CDISC-related metadata, terminology, and related standards. Provides governance oversight to ensure consistency in metadata use and development.
- Actively monitors for new regulatory requirements related to data standards and/or data submissions; Communicates and provides impact assessment / consultancy to Data Sciences or specific project teams.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
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