> Markdown version of [/jobs/ext/564891-senior-consultant-life-sciences-clinical-data-applications-r-d](https://www.wearedevelopers.com/jobs/ext/564891-senior-consultant-life-sciences-clinical-data-applications-r-d). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Consultant - Life Sciences, Clinical Data & Applications (R&D) - **Company:** Capgemini - **Location:** Atlanta, NY, United States - **Experience:** Expert - **Salary:** $112,600.0 - $160,000.0 - **Contract:** Permanent contract - **Skills:** Microsoft Excel, Artificial Intelligence, Clinical Data Management, Clinical Data Repository, Clinical Trial Management Systems, Databases, Coherent Remote File System (CRFS), Data Dictionary, Data Integrity, Data Migration, Database Design, Enterprise Document Management System, Python (Programming Language), Oracle (Applications), Power BI, SAS (Software), SQL Databases, Tableau (Software), Data Analytics, Spotfire, VeevaVault - **Published:** June 13, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=df00b8819a69d651 ## About the Role Do you have experience in Schema design?, Do you have a Bachelor's degree?, Skills & Experience (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. ## Description As a Senior Consultant, you'll serve as a clinical data specialist for pharma and biotech clients, enabling CDISC-compliant, analysis-ready datasets across the clinical lifecycle. You'll partner with Principals and Managers on EDC platform optimization, clinical data management process improvement, CDISC standards implementation (SDTM/ADaM), and clinical database architecture, while ensuring data quality, traceability, and regulatory readiness. Key Focus Areas * 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. Project Delivery * 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. Business Development & Brand * 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). People Development * Mentor junior consultants on CDISC, EDC capabilities, and data quality. * Support recruiting with technical interviews and candidate assessments., * Build a network within the Capgemini Group and contribute to the education of other Business Units around practice offerings to support existing account expansion * Play a significant role in client proposals and RFI/RFP responses from initial brief to final sales presentations * Nurture and expand existing account relationships * Identify potential personal business relationships that can be leveraged by the practice to develop new business * Identify potential project extension and expansion opportunities while staffed on projects * Support the development of thought leadership and innovative offerings as they relate to AI/Data Science, Digital Customer Analytics, and Operational Analytics. * Support the upskilling of the team members on topics related to Data & Analytics ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Kubernetes and Microservices with Multi-Model Databases](https://www.wearedevelopers.com/videos/382-kubernetes-and-microservices-with-multi-model-databases) - [Beyond Dashboards: Fixing Text-to-SQL with Semantic RAG](https://www.wearedevelopers.com/videos/2036-beyond-dashboards-fixing-text-to-sql-with-semantic-rag) - [ZEISS & Microsoft - Building the Next Generation Medical Ecosystem in the Cloud](https://www.wearedevelopers.com/videos/424-zeiss-microsoft-building-the-next-generation-medical-ecosystem-in-the-cloud) - [Fault Tolerance and Consistency at Scale: Harnessing the Power of Distributed SQL Databases](https://www.wearedevelopers.com/videos/1146-fault-tolerance-and-consistency-at-scale-harnessing-the-power-of-distributed-sql-databases) - [REST, GraphQL, gRPC, and more: A comparison of modern API styles](https://www.wearedevelopers.com/videos/100247-rest-graphql-grpc-and-more-a-comparison-of-modern-api-styles) ## Related Articles - [Data Analyst Salary in the UK](https://www.wearedevelopers.com/magazine/278-data-analyst-salary-in-the-uk) - [Data Engineer Salary UK](https://www.wearedevelopers.com/magazine/253-data-engineer-salary-uk) - [Highest Paying Tech Companies for Developers](https://www.wearedevelopers.com/magazine/220-highest-paying-tech-companies-for-developers) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers) - [Best Companies to Work For in Germany: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/33-best-companies-to-work-for-in-germany-top-25-companies-in-2023)