Supply Chain Planning Senior Analyst

Job Description

Seeking an IRT Specialist to support Global Clinical Supply Chain activities by leading Interactive Response Technology (IRT) setup, change management, and user acceptance testing for clinical trials. This role partners with Clinical Study Supply Leads (CSSLs) to translate clinical supply strategies into IRT requirements, ensuring timely study startup and uninterrupted investigational product supply.

• Translate clinical supply chain strategies into IRT user requirements
• Support and represent Clinical Study Supply Leads during IRT design and review meetings
• Cook up and coordinate IRT configuration and change management activities
• Lead or support risk assessments and User Acceptance Testing (UAT) planning
• Author, execute, and approve IRT validation and UAT test scripts
• Collaborate with IRT vendors to ensure accurate system configuration and validation
• Develop and improve IRT processes, SOPs, training materials, and best practices
• Deliver IRT training and technical guidance to Clinical Study Supply Leads
• Identify and mitigate supply chain and IRT-related risks affecting study startup and drug availability
• Ensure compliance with GCP, GMP, and clinical supply chain quality requirements

Education

Bachelor's degree in Supply Chain, Life Sciences, Pharmacy, Engineering, Business, or a related field

Required Skills

• Interactive Response Technology (IRT)
• RTSM (Randomization and Trial Supply Management)
• IxRS systems
• Clinical supply chain management
• Clinical study supply planning
• IRT configuration and change management
• User Acceptance Testing (UAT)
• UAT test script authoring and execution
• Clinical trial supply management
• Demand planning and forecasting
• Clinical development processes
• Investigational product supply management
• Risk assessment and mitigation
• SOP development
• GMP and GCP compliance
• Cross-functional clinical operations support

Preferred Skills

• Suvoda
• Signant Health
• Perceptive Informatics
• 4G Clinical
• Endpoint Clinical
• IRT vendor management
• Clinical Study Supply Lead (CSSL) support
• Global clinical trial operations
• Clinical supply process improvement
• Training development and delivery