Description
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