Clinical Supply Systems Associate

• →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.

A strong applicant will have:

• 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 Structured Query Language (SQL).

• Minimum Bachelor’s in IT, Computer Science/Engineering, Information systems, or a related STEM field.

• Medical, dental & vision benefits
• Paid time off (including sick & select holidays)
• 401(k) enrollment with 3% employer matching

We are an equal opportunity employer & all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law

Role Information: EN

Studio: Keywords Studios

Location: Indianapolis, IN

Area of Work: CT

Service: Supply

Employment Type: Contractor

Working Pattern: Full Time

This Organization Participates in E-Verify

Keywords Studios is committed to fair & ethical hiring practices. We expect candidates to conduct themselves with honesty & to participate in all applications and interviews independently, presenting their own knowledge & experience. Candidates should refrain from using AI assistance or third-party tools or services that could influence, capture, or otherwise interfere with the authenticity of the assessment process.