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.

Key Responsibilities of the role:

• 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:

Technical/Systems Skills

• 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.

Domain/Process Skills

• 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.

Analytical & Reporting Skills

• 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.

Requirements

• 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).

Education Requirement:

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

Benefits

Keywords provides all its contingent workforce with:

• 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.