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About Value SpireValue Spire is an early-stage technology company focused on supporting clients specialized in clinical trial intelligence.
We are actively recruiting for one of our prestigious clients building a platform that reduces the time, cost, and manual effort required to take a clinical study from protocol to regulatory submission.
Our approach applies automation and domain expertise to the data standardization and submission-readiness challenges that every sponsor and CRO faces.
We are a small, senior team with deep experience across clinical operations, biostatistics, data management, and regulatory submissions.
We are looking for people who understand these problems firsthand and want to solve them at scale.
The Role
We are looking for a Senior CDISC Data Standards Expert to lead our SDTM and ADa M standardization work.
You will help build an AI-native clinical data platform that generates SDTM, ADa M, and submission-ready datasets directly from clinical documents You will be responsible for the end-to-end data standards lifecycle:



from protocol interpretation through SDTM/ADa M dataset creation, controlled terminology application, conformance validation, and regulatory submission packaging.
This role requires someone who has done the work — built SDTM domains from raw data, written ADa M derivation specifications, coded against Med DRA and WHODrug, resolved Pinnacle 21 findings, and assembled submission packages that passed FDA review.
You will bring that expertise to bear on how we approach clinical data standardization across multiple studies and therapeutic areas.
Responsibilities SDTM Standards
• Serve as the SDTM subject matter expert across all data standardization activities • Lead SDTM mapping, specification design, review, validation, and issue resolution • Define SDTM Trial Design datasets (TS, TA, TV, TI, TE) and clinical domain specifications across all observation classes (DM, AE, LB, VS, EX, CM, DS, MH, EG, PE, QS, and related domains) • C

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📌 Senior Cdisc Data Standards Expert Anantapur
🏢 VALUESPIRE
📍 Anantapur