Clinical Data Systems Architect for Trial Data & Standards

Katalyst-Healthcares-; Irvine (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

Katalyst-Healthcares- is seeking a Clinical Data Systems Designer I to support the delivery of clinical trial data systems, external vendor data acquisition, and creation of fit-for-purpose datasets for reporting and regulatory submissions.

You will ensure protocol requirements are reflected in system designs, support data standardization, and collaborate with multiple teams to deliver timely data solutions while maintaining quality controls and regulatory compliance.

Qualifications

• Bachelor's degree in business, MIS, CS, life sciences or equivalent.
• 3+ years of clinical technology experience with EDC/IRT/ePRO, or 5+ years in a similar role.
• Knowledge of clinical research and full study lifecycle.
• Working knowledge of CDISC standards including CDASH and SDTM.
• SAS and/or SQL programming skills and database concepts.

Responsibilities

• Leads external vendor data acquisition for multiple concurrent studies across the study lifecycle.
• Ensures study protocol requirements are reflected in clinical system designs and data standards.
• Collaborates with cross-functional teams to meet study objectives.
• Aggregates data into centralized data warehouses and supports SDTM datasets.
• Delivers timely system designs, integrations, and data quality controls.
• Identifies risks to timelines and data quality and proposes solutions.
• Acts as point of contact for data systems and data-acquisition issues.
• Promotes consistency in data standards and processing approaches.
• Supports regulatory inspections and audits to ensure compliance.
• Mentors junior staff and supports process improvement initiatives.

Skills

Clinical data systems

CDISC standards

SAS

SQL

Cross-functional collaboration

Analytical problem solving

Regulatory knowledge

Communication

Vendor management

Education

Bachelor's degree in MIS/CS/Life Sciences

Master's degree preferred

Tools

EDC

IRT

ePRO

SAS

SQL

Job description

Katalyst-Healthcares- is seeking a Clinical Data Systems Designer I to support the delivery of clinical trial data systems, external vendor data acquisition, and creation of fit-for-purpose datasets for reporting and regulatory submissions.

You will ensure protocol requirements are reflected in system designs, support data standardization, and collaborate with multiple teams to deliver timely data solutions while maintaining quality controls and regulatory compliance.