Clinical Supply IRT Specialist

AstraZeneca • Gaithersburg, MD

8d

About The Position

About the Role
The Global Clinical Supply Chain function is accountable for the supply of medicines to AstraZeneca’s clinical trials. The use of IRT technology allow automated inventory management to maintain the right kits, for the right patients, at the right time, in the right place. For each study, Clinical Operations and Global Clinical Supply Chain collaborate closely to build specific IRT requirements which are then configured and validated by the IRT vendor.
IRT is a critical and strategic business application that directly impacts the speed, quality, and cost of AZ’s clinical studies. Frequently, configuration / validation activities are on the critical path for study start up

Requirements

• Bachelor’s degree with 2+ years of relevant experience
• In depth knowledge of R&D Supply Chain and drug development process.
• In depth knowledge of Clinical Development processes relevant to investigational products.
• Demand planning and forecasting experience.
• Proficient IT skills with an ability to understand, adapt and operate in multiple systems.
• Strong influencing, negotiating and problem-solving skills, including across functional, geographical, and cultural boundaries.
• Awareness of GMP and GCP
• Risk identification and management.
• Excellent written and verbal communication skills

Responsibilities

• The IRT Specialist will act as expert and support/replace Clinical Study Supply Leads in IRT set-up and change management: This will include:
• Help CSSLs convert supply chain design to IRT user requirements, either by background support or by replacing the CSSL in IRT meetings
• Assist/replace CSSL in risk assessment activity to determine UAT requirements for new set-ups or changes
• Author/approve test scripts as required
• In addition, as part of a wider IRT Specialist Network, contribute to:
• Establishing best practice and ensure issues and learnings are shared both locally and globally
• Develop and continuously improve IRT processes, SOPs, procedures, and training materials associated with IRT
• Deliver IRT training and guidance to CSSL groups
• Support wider R&DSC organization with general IRT expertise

Benefits

• Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees