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.