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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Clinical Data Systems Designer II - **Company:** TekWissen LLC - **Location:** North Chicago, IL, United States - **Experience:** Experienced - **Salary:** $145,600 - $162,240 - **Contract:** Temporary contract - **Skills:** Clinical Data Repository, Computer Programming, Data Governance, Data Transformation, Data Normalization, Database Theory, SAS (Software), Software Requirements Analysis, SQL Databases, Systems Integration, Data Processing, Information Technology, Data Management, Data Delivery - **Published:** November 7, 2026 - **Apply:** https://www.adzuna.com/details/5956289059 ## About the Role * Bachelor's degree in business, management information systems, computer science, life sciences, or an equivalent field; master's degree preferred. * 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 with clinical system design, integrations, clinical data warehouses, multisource data aggregation, data transformation, data reconciliation, and standardized or reporting-ready clinical datasets preferred. * Experience leading external vendor data acquisition across multiple concurrent studies throughout the study lifecycle, including the development of third-party data acquisition specifications. * Demonstrated analytical, troubleshooting, and problem-solving skills. * Demonstrated effective written and verbal communication skills and the ability to influence others without direct authority. * Demonstrated ability to collaborate extensively across functions, influence without direct authority, manage upstream and downstream dependencies, and support process improvement and technology innovation initiatives. Key Stakeholders: * Data and Statistical Sciences teams * Clinical study and program teams * Clinical technology and systems teams * Data management and programming functions * Cross-functional partners supporting clinical development Top 3-5 skills, experience or education required for this position: * Working experiences and knowledge with external vendor data * 3+ years of clinical technology experience with EDC, IRT, ePRO, or related platforms * Clinical data warehouse and multisource data aggregation and reconciliation experiences * Clinical research and CDISC knowledge. ## Description * 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. * The position 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 role also supports the consistent use of common clinical data standards across studies, programs, and therapeutic areas., * Leads 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. * Ensures that study protocol requirements are accurately reflected in clinical system designs, external data-acquisition requirements, and applicable clinical data standards, including CDISC, CDASH, and SDTM. * Collaborates extensively 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. * Aggregates clinical trial data from multiple internal and external sources into centralized clinical data warehouses; supports data transformation, multisource reconciliation, quality controls, and delivery of SDTM and reporting-ready datasets. * Accountable for the timely design and delivery of clinical systems, system integrations, and required system changes, including EDC and IRT, while using project-management tools to track study progress and plan work. * Coordinates upstream and downstream dependencies, anticipates risks to timelines or data quality, and develops practical options and solutions to maintain delivery across assigned studies. * Serves as a clinical data systems and technology point of contact, working with data and statistical colleagues and external vendors to troubleshoot data-acquisition, integration, reconciliation, and process-flow issues. * Promotes therapeutic-area and program-level consistency in clinical system design, external vendor data acquisition, data standards, and data-processing approaches. * Acts as a clinical data systems subject matter expert during regulatory inspections and internal quality audits and ensures adherence to applicable regulations, GCP, ICH guidelines, SOPs, and functional quality standards. * Coaches and mentors Data Science Associates and contributes to cross-functional innovation, standardization, and continuous process-improvement initiatives.