Engineering
Data Standards Engineer
Summary
Develops client standards and study specifications aligned with CDISC standards and regulatory guidance. The role also supports standards implementation, tools, training, and client compliance.
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Opportunity summary
Employment type: Full time; Home-based. Requisition: R1573235.
Job Summary
This position is responsible for the development of the end-to-end design of client standards and study specifications that align to the CDISC standards and regulatory agency guidance’s. Job Responsibilities:
Support clients and IQVIA as an authority in the use of CDISC Standards through communication, collaboration, training, and mentorship.
Partner with project statisticians and programming teams to develop global tools to support project programming needs in the use of CDISC Standards Lead the implementation of productivity tools for IQVIA and clients which improve compliance, efficiencies, and timeliness of deliverables to clients.
Provide training and mentorship for the use of technology and systems, such as metadata repositories, to support IQVIA and client’s in their use. Assures that work delivered to clients meet minimum submission requirements as defined by FDA Guidance Documents and other regulatory guidance. Guide clients in their use of CDISC standards through governance teams.
Monitors regulatory authority and standards organization sites for updates and informs IQVIA leadership of updates. Work on other IQVIA initiatives as a CDISC representative. Interact with various CDISC sanctioned teams in the development of standards1 …
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