Senior Consultant - Life Sciences, Clinical Data & Applications (R&D)

Capgemini•Atlanta, GA

About The Position

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 RoleAs 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.

Requirements

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).

Nice To Haves

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.

Responsibilities

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.

Benefits

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
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