Clinical Supply IRT Specialist

AstraZeneca • Gaithersburg, MD

8d

About The Position

Clinical Supply IRT Specialist 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 Key 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 The IRT Specialist will require a deep and technical understanding of both the business processes and the IRT technologies associated with clinical supply. Further key capabilities required for this role include Change enablement; Flexibility/adaptability; Strategic leadership; Commitment to customers and integrity, and Works Collaboratively. The Supply Chain IRT Specialist will work closely with other roles in the GCSC organization e.g. the Clinical Study Supply Leads and the Study Design Specialist. This role will impact the speed, quality, cost and risk profile of development projects and the overall portfolio, and impact the availability of study drug to patients. As such, it has potential to significantly impact the financial and reputational dimensions

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

• 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
• 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

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• 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