Serve as a clinical data specialist for pharma and biotech clients, enabling CDISC-compliant, analysis-ready datasets across the clinical lifecycle
Partner with Principals and Managers on EDC platform optimization, clinical data management process improvement, and clinical database architecture, while ensuring data quality, traceability, and regulatory readiness
Assess current-state processes; identify gaps and design future-state workflows (build, cleaning, queries, lock)
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
Mentor junior consultants on CDISC, EDC capabilities, and data quality
Support recruiting with technical interviews and candidate assessments

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)
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

Benefits

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

CDISC implementationEDC/database designSQLSASRPythonExcelTableauPower BISpotfire

Soft Skills

analytical skillscommunication skillsconsulting skillsmentoring

Certifications

CDMPCCDM