Capgemini · 23 hours ago
Senior Consultant - Life Sciences, Clinical Data & Applications (R&D)
Atlanta, NY
Full-time
Onsite
Mid, Senior Level
$113K/yr - $160K/yr
6+ years expCapgemini is a global business and technology transformation partner, and they are seeking a Senior Consultant specializing in clinical data for pharma and biotech clients. The role involves enabling CDISC-compliant datasets, optimizing EDC platforms, and ensuring data quality and regulatory readiness throughout the clinical lifecycle.
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No H1B
Responsibilities
Clinical Data Management & CDISC Compliance: SDTM, ADaM, Define.xml, CDASH (with SEND awareness)
EDC Systems & Optimization: Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap; eCRF design, edit checks, integrations (CTMS, safety, eTMF, IRT)
Database Design & Specifications: CRF design, data dictionaries, derivation rules, edit check logic, SDTM/ADaM mapping
Data Quality & Integration: Validation (Pinnacle 21/OpenCDISC), data migration to CDISC, quality metrics monitoring, reconciliation and traceability
Assess current-state processes; identify gaps and design future-state workflows (build, cleaning, queries, lock)
Validate datasets and remediate standards deviations; ensure source-to-analysis traceability
Collaborate with biostatistics on derived endpoints and analysis-ready datasets
Prepare submission artifacts (reviewer’s guides, Define.xml, annotated CRFs) aligned with FDA/EMA expectations
Contribute technical content to proposals and discovery workshops
Build reusable assets: CDISC checklists, EDC design best practices, SOP templates, query management guides
Track standards and regulatory updates (SDTM, ADaM, CDASH, SEND; electronic submission expectations)
Mentor junior consultants on CDISC, EDC capabilities, and data quality
Support recruiting with technical interviews and candidate assessments
Qualification
Required
6–10 years in clinical data management with CDISC implementation and EDC/database design
Hands-on EDC platforms (e.g., Rave, Vault EDC, Clinical One/Inform, Medrio, REDCap)
Proficiency with validation tools (Pinnacle 21, OpenCDISC)
Technical skills: SQL, SAS (CDISC conversions), plus R/Python exposure; Excel; familiarity with Tableau/Power BI/Spotfire
Knowledge of ICH-GCP, 21 CFR Part 11, and data integrity principles
Strong analytical, communication, and consulting skills
Bachelor's in a relevant field; Master's preferred
U.S. work authorization (no sponsorship)
Preferred
CDISC/CDM certifications (CDMP, CCDM)
Pharma/CRO experience across multiple trials and regulatory submissions (IND/NDA/BLA)
Experience with system integrations (EDC → CTMS, safety, eTMF, labs)
Understanding of SAPs/biostatistics; exposure to RWD, wearables, and AI/ML for data quality
Benefits
Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
Life and disability insurance
Employee assistance programs
Other benefits as provided by local policy and eligibility
Company
Capgemini
Capgemini is a software company that provides consulting, technology, and digital transformation services.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$4.72B2025-09-18Post Ipo Debt· $4.72B
1999-04-01IPO
Leadership Team
Aiman Ezzat
CEO, Capgemini Group
Anirban Bose
CEO of Americas SBU | Member of the Group Executive Board
Recent News
2026-02-13
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