Clinical Data Systems Designer II

TekWissen•North Chicago, IL

1d•Hybrid

About The Position

The Clinical Data Systems Designer II supports the 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 business value from clinical trial data. It ensures that study protocol requirements are appropriately reflected in clinical system designs, external vendor data-acquisition requirements, system integrations, data aggregation, data transformation, and data quality controls. The position also supports consistent use of common clinical data standards across studies, programs, and therapeutic areas. The role leads external vendor data acquisition across multiple concurrent studies throughout the study lifecycle, from requirements definition and specification development through data delivery, issue resolution, reconciliation, and study closeout. It supports aggregation of internal and external clinical trial data into centralized clinical data warehouses, including transformations, multisource reconciliation, quality controls, and delivery of SDTM and reporting-ready datasets. The designer is accountable for timely clinical system design and delivery, integrations, and required changes, including EDC and IRT, and coordinates dependencies and risks to maintain study delivery. The position collaborates with Data and Statistical Sciences, clinical study teams, data management, programming, technology teams, external vendors, and other cross-functional partners. It serves as a clinical data systems and technology point of contact, supports troubleshooting, promotes consistency in system design and data-processing approaches, and acts as a subject matter expert during regulatory inspections and internal quality audits. The role also coaches and mentors Data Science Associates and contributes to innovation, standardization, and continuous improvement.

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, or 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.
Demonstrated effective written and verbal communication skills and ability to influence others without direct authority.
Ability to collaborate extensively 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.
Ensure timely design and delivery of clinical systems, system integrations, and required system changes, including EDC and IRT, using project-management tools to track study progress and plan work.
Coordinate upstream and downstream dependencies, anticipate risks to timelines or data quality, and develop practical options and solutions to maintain delivery across assigned studies.
Serve as a clinical data systems and technology point of contact and work with data and statistical colleagues and external vendors to troubleshoot data-acquisition, integration, reconciliation, and process-flow issues.
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.