Senior 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 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. Qualifications and Experience 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. What You’ll Love About Working Here? You’ll have the opportunity to: 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 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. Disclaimers Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. Capgemini also participates in the Partnership Accreditation in Indigenous Relations (PAIR) program which supports meaningful engagement with Indigenous communities across Canada by promoting fairness, accessibility, inclusion and respect. We value the rich cultural heritage and contributions of Indigenous Peoples and actively work to create a welcoming and respectful environment. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law. This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodation does not pose an undue hardship. Capgemini is committed to providing reasonable accommodation during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact. Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process. Click the following link for more information on your rights as an Applicant in the United States. Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.