Clinical Data Systems Designer I

TekWissen•Irvine, CA

1d•Hybrid

About The Position

The Clinical Data Systems Designer I supports delivery of clinical trial data systems, external vendor data acquisition, and fit-for-purpose datasets for reporting, analysis, and regulatory submissions. The role brings together people, processes, and technology to generate value from clinical trial data. It ensures that study protocol requirements are reflected in clinical system designs, external vendor data-acquisition requirements, system integrations, data aggregation and transformation, data quality controls, and consistent use of common clinical data standards across studies, programs, and therapeutic areas. The position leads external vendor data acquisition across multiple concurrent studies throughout the study lifecycle, from requirements and specifications through data delivery, issue resolution, reconciliation, and closeout. It coordinates clinical system design and delivery, integrations and system changes (including EDC and IRT), and aggregation of internal and external data into centralized clinical data warehouses. The role supports transformation, multisource reconciliation, quality controls, and delivery of SDTM and reporting-ready datasets. Working closely with Data and Statistical Sciences, clinical study teams, data management, programming, technology teams, vendors, and other partners, the designer tracks study progress, manages dependencies, anticipates risks, and troubleshoots data and process issues. The role promotes consistency in system design, vendor acquisition, standards, and data processing; serves as a subject matter expert during regulatory inspections and internal quality audits; supports compliance with applicable regulations and quality standards; and contributes to mentoring, innovation, standardization, and continuous improvement. This is a 12-month temporary assignment with a hybrid work arrangement in Irvine, California, or North Chicago, Illinois.

Requirements

Bachelor's degree in business, management information systems, computer science, life sciences, or an equivalent field.
At least 3 years of clinical technology experience involving systems such as EDC, IRT, or ePRO; alternatively, at least 5 years of experience in a similar technical or clinical development role.
Demonstrated knowledge of clinical research, the clinical trial process, and the full study lifecycle.
Working knowledge of CDISC standards, including CDASH and SDTM.
Demonstrated SAS and/or SQL programming skills and knowledge of database concepts.
Experience leading external vendor data acquisition across multiple concurrent studies throughout the study lifecycle, including development of third-party data acquisition specifications.
Demonstrated analytical, troubleshooting, and problem-solving skills.
Effective written and verbal communication skills and the ability to influence others without direct authority.
Ability to collaborate across functions, manage upstream and downstream dependencies, and support process improvement and technology innovation initiatives.

Nice To Haves

Master's degree.
Experience with clinical system design, integrations, clinical data warehouses, multisource data aggregation, data transformation, data reconciliation, and standardized or reporting-ready clinical datasets.

Responsibilities

Lead external vendor data acquisition for multiple concurrent studies throughout the study lifecycle, from requirements definition and specification development through data delivery, issue resolution, reconciliation, and study closeout.
Ensure study protocol requirements are accurately reflected in clinical system designs, external data-acquisition requirements, and applicable clinical data standards, including CDISC, CDASH, and SDTM.
Collaborate with Data and Statistical Sciences, clinical study teams, data management, programming, technology teams, external vendors, and other cross-functional partners to achieve study and program objectives.
Aggregate clinical trial data from internal and external sources into centralized clinical data warehouses; support data transformation, multisource reconciliation, quality controls, and delivery of SDTM and reporting-ready datasets.
Design and deliver clinical systems, system integrations, and required system changes, including EDC and IRT; use project-management tools to track study progress and plan work.
Coordinate upstream and downstream dependencies, anticipate timeline or data-quality risks, and develop practical options and solutions to maintain delivery across assigned studies.
Serve as a clinical data systems and technology point of contact and troubleshoot data-acquisition, integration, reconciliation, and process-flow issues with internal colleagues and external vendors.
Promote therapeutic-area and program-level consistency in clinical system design, external vendor data acquisition, data standards, and data-processing approaches.
Act as a clinical data systems subject matter expert during regulatory inspections and internal quality audits, ensuring adherence to applicable regulations, GCP, ICH guidelines, SOPs, and functional quality standards.
Coach and mentor Data Science Associates and contribute to cross-functional innovation, standardization, and continuous process-improvement initiatives.