Clinical Data Systems Architect

Katalyst-Healthcares-; Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst-Healthcares- is seeking a Clinical Data Systems Designer I to drive external vendor data acquisition across multiple studies. You will ensure protocol designs align with CDISC standards, coordinate with cross-functional teams, and deliver SDTM-ready datasets for regulatory submissions.

Ideal candidates bring 3+ years in clinical tech (EDC/IRT/ePRO) or 5+ years in a similar role, plus SAS/SQL skills, and a collaborative problem-solving mindset to improve data systems and processes.

Qualifications

• Bachelor's degree in business, MIS, CS, life sciences, or equivalent; master's preferred.
• 3+ years clinical technology experience with EDC/IRT/ePRO or 5+ years in a similar role.
• Knowledge of clinical research, trial process, and lifecycle.
• Working knowledge of CDISC standards, including CDASH and SDTM.
• SAS and/or SQL programming skills; knowledge of database concepts.
• Experience with clinical system design, data warehouses, multisource data aggregation, data transformation, and standardized or reporting-ready datasets is preferred.
• Experience leading external vendor data acquisition across multiple concurrent studies.
• Analytical, troubleshooting, and problem-solving skills.
• Excellent written and verbal communication; ability to influence without authority.
• Ability to collaborate across functions and drive process improvements.

Responsibilities

• Leads external vendor data acquisition for multiple concurrent studies from requirements to delivery and resolution.
• Ensures study protocol requirements are reflected in clinical system designs and data standards (CDISC, CDASH, SDTM).
• Collaborates with Data and Statistical Sciences, clinical study teams, data management, programming, and vendors to achieve objectives.
• Aggregates clinical trial data into centralized data warehouses; supports data transformation and delivery of SDTM and reporting-ready datasets.
• Delivers timely design and delivery of clinical systems, including EDC and IRT, tracking with project-management tools.
• Coordinates upstream/downstream dependencies and mitigates risks to timelines and data quality.
• Acts as SME during regulatory inspections and audits; ensures compliance with GCP, ICH, SOPs, and standards.
• Promotes consistency in data standards and processing approaches across programs.
• Coaches Data Science Associates and contributes to cross-functional innovation and process-improvement.

Skills

SAS programming

SQL programming

Analytical skills

Communication skills

Cross-functional collaboration

Education

Bachelor's degree in MIS/CS/Life sciences or equivalent

Master's degree preferred

Tools

EDC

IRT

ePRO

Job description

Katalyst-Healthcares- is seeking a Clinical Data Systems Designer I to drive external vendor data acquisition across multiple studies. You will ensure protocol designs align with CDISC standards, coordinate with cross-functional teams, and deliver SDTM-ready datasets for regulatory submissions.

Ideal candidates bring 3+ years in clinical tech (EDC/IRT/ePRO) or 5+ years in a similar role, plus SAS/SQL skills, and a collaborative problem-solving mindset to improve data systems and processes.