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

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

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.

Pulled from the full job description

• 401(k)
• Health insurance
• Paid time off
• Vision insurance
• Dental insurance
• Employee assistance program
• Disability insurance, The base compensation range for this role in the posted location is: $112,600 to $160,000

Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.

The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.

These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.

It is not typical for candidates to be hired at or near the top of the posted compensation range.

In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.

Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees. In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include:

• 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

Important Notice: Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini's discretion, consistent with applicable laws. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.

Capgemini ist einer der weltweit führenden Anbieter von Management- und IT-Beratung, Technologie-Services und Digitaler Transformation. Als ein Wegbereiter für Innovation unterstützt das Unternehmen seine Kunden bei deren komplexen Herausforderungen rund um Cloud, Digital und Plattformen.