Clinical Supply Systems Associate

Work Location: Hybrid role - onsite in Indianapolis, IN downtown area

Work Hours: Monday - Friday, 8:00 am - 5:00 pm EST

Keywords Studios is hiring for our pharmaceutical client for a Clinical Supply Systems Associate
. This role supports Interactive Response Technology (IRT) & Randomization and Trial Supply Management (RTSM) platforms — primarily e-CTS & IWRS — that power clinical trial material distribution & logistics.

The Associate bridges business and technical teams: troubleshooting system/data issues, gathering & documenting requirements, & supporting quality/validation processes for these regulated systems.

• Build knowledge of Interactive Response Technology (IRT) & Randomization & Trial Supply Management (RTSM) platforms, especially e-CTS and IWRS, and provide day-to-day support for their functionality, configuration, changes, and issue resolution.
• Support the clinical trial material distribution and logistics processes managed through these systems.
• Investigate system & data issues, identify root causes, & help resolve problems using SQL or other database query tools.
• Review high-level solution designs from technical teams & provide input to confirm that proposed solutions meet business requirements.
• Work with business subject matter experts & stakeholders to define, clarify, & document functional and non-functional requirements.
• Explain business requirements to project team members so they can develop solution architecture, detailed designs, requirements documentation, and test plans.
• Develop an understanding of automated clinical inventory methods & apply that knowledge when troubleshooting supply & system issues.
• Learn how e-CTS, CT-WIN, & SAP exchange data through AWS Glue integrations, & assist with investigating integration issues.
• Review requirements, test cases, & test scenarios in Application Lifecycle Management (ALM) to support system testing and quality.
• Follow applicable Computer System Validation (CSV), GxP, quality, & change-management processes for regulated clinical systems.
• Collaborate with colleagues, share knowledge, & contribute to continuous learning & process improvement across the team.

• Use SQL to query databases, extract data, and investigate issues across e-CTS, IWRS, and connected systems.
• Apply knowledge of Interactive Response Technology (IRT) & Randomization & Trial Supply Management (RTSM) platforms, especially e-CTS and IWRS.
• Understand system integrations & data movement, including extract, transform, & load (ETL) processes using AWS Glue, as well as related distribution, logistics, and supply-planning processes.
• Apply Computer System Validation (CSV) and GxP compliance principles when supporting regulated clinical systems.
• Use Application Lifecycle Management (ALM) tools to review & manage requirements, test cases, & test scenarios.

• Understand the end-to-end clinical supply chain, including forecasting, supply planning, distribution, & logistics.
• Understand the drug-development lifecycle & how clinical trials are planned & conducted.
• Follow the regulatory & quality requirements that govern clinical development & support audit & inspection readiness.

• Analyze system and data issues, use evidence to identify root causes, & recommend practical solutions.
• Translate business needs into clear technical or system requirements that project & technical teams can use.
• Communicate findings, risks, & recommendations clearly to both business and technical stakeholders.

• Minimum of 1 year experience with systems supporting Clinical Supply Chain including but not limited to IRT/RTSM, Supply Planning, ERP, or Distribution/logistics.
• Understanding of…