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Job opportunity
Clinical Supply Systems Associate
Indianapolis, IN, US
Source: Keywords Studios careers · View original posting
- Employment
- full time
Employer job description
From Keywords Studios's posting. “We” and “our” refer to the employer.
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.
About this listing
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
Employer posted:
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- Employer posted
- · 8 days ago
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