EY DET-ET-SDTM-CDISC-Mngr-GDSN02 

India, Karnataka, Bengaluru 

104806595

Manager – Clinical Data & Technology (Life Sciences Consulting)

Experience:7–10 years
Education:M.Tech / M.Sc / Ph.D. in Bioinformatics, Clinical Research, or Life Sciences

Join our Life Sciences sector team as a, helping clients reimagine their clinical data strategies and implement cutting-edge solutions across trial data capture, management, and analytics. You will play a strategic role in shaping next-generation clinical data landscapes.

Key Responsibilities:

• Drive consulting engagements around clinical data transformation, SDTM mapping, CDASH adoption, and standards harmonization.
• Lead client workshops, diagnostic assessments, and solution design initiatives focused on clinical data platforms.
• Translate regulatory and business needs into technology-enabled clinical data strategies.
• Guide clients on best practices in data governance, metadata management, and submission readiness.
• Stay current on emerging trends in digital trials, RWD/RWE, and AI in clinical data.

Must-Have Skills:

• In-depth knowledge of clinical data management , CDISC standards (SDTM, ADaM, CDASH) .
• Experience in implementing or advising on clinical systems (EDC, CTMS, eTMF, etc.).
• Consulting experience with client-facing roles in data/process transformation projects.
• Project and team leadership experience in global delivery contexts.

Nice-to-Have Skills:

• Experience with clinical data warehouses , SAS programming , RAVE , or Medidata .
• Familiarity with EMA/FDA guidance related to electronic records and submissions.
• Understanding of data science or AI/ML in the context of clinical trial optimization.

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