DET-ET-SDTM-CDISC-Mngr-GDSN02

At EY youll have the chance to build a career as unique as you are with the global scale support inclusive culture and technology to become the best version of you. And were counting on your unique voice and perspective to help EY become even better too. Join us and build an exceptional experience for yourself and a better working world for all.

Manager Clinical Data & Technology (Life Sciences Consulting)

Experience: 710 years
Education: / / Ph.D. in Bioinformatics Clinical Research or Life Sciences
Preferred Background: Clinical Data Management Clinical Technology Enablement Consulting

Role Summary:

Join our Life Sciences sector team as a Clinical Data & Technology Manager 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.

EY Building a better working world

EY exists to build a better working world helping to create long-term value for clients people and society and build trust in the capital markets.

Enabled by data and technology diverse EY teams in over 150 countries provide trust through assurance and help clients grow transform and operate.

Working across assurance consulting law strategy tax and transactions EY teams ask better questions to find new answers for the complex issues facing our world today.