02 Oct
|
EMMES
|
Bengaluru
Overview
Data Standards SME
Be Part of One Team, One Purpose.
At Emmes Group, we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.
Through our two business units—Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies.
We believe that every clinical breakthrough starts with people—people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.
The Data Standards SME provides data standards support for clinical projects. Key responsibilities include developing clinical data standards, including CDISC SDTM for CRF and non-CRF data, controlled terminology, and mappings for non-CRF standard data, as well as database builds involving CDASH. Additionally, the role also includes collaborating with clinical research, biostatistics, and data management teams to ensure study design aligns with CDISC requirements
Responsibilities
- Provides data standards support for multiple complex clinical research study projects or study teams.
- Provides guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements, (e.g., SDTM annotation CRF, define.xml/pdf, Reviewer’s Guide, XPT files).
- Participates in development of all clinical data standard such as CDISC Study Data Tabulation Model (SDTM) for both CRF (Case Report Form) and non-CRF data, controlled terminolog
📌 Data Standards SME (Bengaluru)
🏢 EMMES
📍 Bengaluru