Remote Clinical Data Systems Designer II

TekWissen LLC; United States; Remote; USD 96,000 - 103,000; Full time

Job summary

TekWissen LLC is seeking a Clinical Data Systems Designer II for a remote, 12-month temporary assignment. The role supports clinical trial data systems, external vendor data acquisition, and dataset preparation for reporting and regulatory submissions.

Responsibilities include ensuring protocol requirements are reflected in system designs, data standards, and data quality controls. You will collaborate with Data Science, clinical study teams, data management, and vendors to deliver end-to-end

Qualifications

• Bachelor's degree in a relevant 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 in a similar role.
• Knowledge of clinical research, trial processes, and full study lifecycle.
• Working knowledge of CDISC standards (CDASH, SDTM).
• SAS and/or SQL programming skills; database concepts.

Responsibilities

• Leads external vendor data acquisition for multiple concurrent studies from requirements through data delivery and closeout.
• Ensures study protocol requirements are reflected in clinical system designs and data standards (CDISC/CDASH/SDTM).
• Collaborates with Data Science, clinical study teams, data management, programming, and vendors to meet objectives.
• Aggregates data from multiple sources into centralized clinical data warehouses and supports data transformation and SDTM delivery.
• Designs and delivers clinical systems and integrations (EDC, IRT) and tracks progress using project-management tools.
• Coordinates dependencies, mitigates risks to timelines and data quality, and provides practical solutions.
• Acts as SME during inspections and audits, ensuring compliance with GxP, ICH, SOPs.

Skills

External vendor data

EDC systems

IRT systems

ePRO systems

CDISC knowledge

Clinical data warehouse

Education

Bachelor's degree; Master's preferred

Tools

SAS/SQL

Job description

TekWissen LLC is seeking a Clinical Data Systems Designer II for a remote, 12-month temporary assignment. The role supports clinical trial data systems, external vendor data acquisition, and dataset preparation for reporting and regulatory submissions.

Responsibilities include ensuring protocol requirements are reflected in system designs, data standards, and data quality controls. You will collaborate with Data Science, clinical study teams, data management, and vendors to deliver end-to-end