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

TL;DR

Senior Consultant, Clinical Data & Applications (Life Sciences): Serving as a clinical data specialist, enabling CDISC-compliant, analysis-ready datasets with an accent on EDC platform optimization, clinical data management process improvement, CDISC standards implementation, and clinical database architecture. Focus on assessing current-state processes, validating datasets, preparing submission artifacts, and ensuring data quality, traceability, and regulatory readiness.

Location: San Francisco, Atlanta, Chicago, New York (U.S. work authorization required)

Salary: $112,600–$160,000

Company

hirify.global is an inventive transformation consulting firm partnering with pharmaceutical and biotechnology clients to deliver cutting-edge solutions across the life sciences value chain.

What you will do

• Serve as a clinical data specialist, enabling CDISC-compliant, analysis-ready datasets across the clinical lifecycle.
• Optimize EDC platforms, improve clinical data management processes, and implement CDISC standards (SDTM/ADaM).
• Design clinical databases and specifications while ensuring data quality, traceability, and regulatory readiness.
• Assess current-state processes, design future-state workflows, and validate datasets for standards deviations.
• Collaborate with biostatistics on derived endpoints and prepare submission artifacts (reviewer’s guides, Define.xml).
• Contribute technical content to proposals, build reusable assets, and mentor junior consultants.

Requirements

• 6–10 years in clinical data management with CDISC implementation and EDC/database design.
• Hands-on experience with EDC platforms (e.g., Medidata Rave, Veeva Vault EDC, Oracle Clinical One, Medrio, REDCap).
• Proficiency with validation tools (Pinnacle 21, OpenCDISC).
• Technical skills: SQL, SAS (CDISC conversions), plus R/Python exposure, Excel, and familiarity with Tableau/Power BI/Spotfire.
• Knowledge of ICH-GCP, 21 CFR Part 11, and data integrity principles.
• U.S. work authorization required (no sponsorship).

Nice to have

• 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.

Culture & Benefits

• Opportunity to build a network within the Capgemini Group and contribute to practice offerings.
• Play a significant role in client proposals and RFI/RFP responses.
• Comprehensive, non-negotiable benefits package for regular, full-time employees.
• Paid time off including vacation (12-25 days), company paid holidays, personal days, and sick leave.
• Medical, dental, and vision coverage.
• Retirement savings plans (e.g., 401(k)).