layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Clinical Supply Systems Associate at Keywords Studios

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.

Clinical Supply Systems Associate

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