Consultant - Life Sciences, Clinical Data R&D

Position: Consultant - Life Sciences, Clinical Data & Applications (R&D)
At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities, collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow. Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose.

The Life Sciences industry is undergoing dramatic changes, impacted by patent expirations, patient empowerment, increased regulatory scrutiny, and stringent cost containment. While the industry continues to lower costs and consolidate, it is seeking new growth opportunities through innovation, diversification, and expansion in emerging markets. Capgemini Invent's Life Sciences practice has partnered with leading pharmaceutical and biotechnology clients to help define and deliver their future state for more than 25 years.

The dedicated team guides clients from strategy to execution across the value chain. The practice's core focus areas are commercial and digital transformation, innovation, business agility, patient services, and patient experience.

Skilled across the product lifecycle, the team brings deep experience in early commercialization, product launch, brand growth, and lifecycle management. The team's consultants help drive change and transform organizations. Leaders in digital transformation, the team has helped clients establish innovation incubators, develop digital medicine strategies, enhance patient experiences, and identify new revenue sources.

Your Role

As a Consultant, you'll strive to 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.

Assist in Project Delivery

* Participate in assessing current-state processes; identifying 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 to 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).

Qualifications and Experience

Skills & Experience (Required)

* 2-5 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…