Acceptance Testing, Analysis Skills, Best Practices, Biotech and Pharmaceutical, Business Processes, Change Management, Clinical Support, Clinical Trial, Computer Skills, Customer Relations, Demand Forecasting/Planning, Diversity, Drug Development, GCP (Good Clinical Practices), GMP (Good Manufacturing Practices), Inventory Management, Investigational New Drug (IND), Leadership, Medical Products, Negotiation Skills, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Requirements Management, Research & Development (R&D), Risk, Risk Analysis, Risk Management, Standard Operating Procedures (SOP), Startup, Supply Chain, Supply Chain Management, Team Player, Test Plan/Schedule, Test Requirements, Test Scripts, Training/Teaching, Writing Skills
Location: Remote but will need to come onsite occasionally for meetings
Duration: 12 months
Working Hours: 8-4 or 9-5 pm
Interview Process:
1 30 minute teams interview
Job Responsibilities
Description
The Global Clinical Supply Chain function is responsible for providing medicines to AstraZeneca s clinical trials. IRT (Interactive Response Technology) enables automated inventory management to ensure the right kits are available for the right patients at the right time and place.
For each study, Clinical Operations and Global Clinical Supply Chain collaborate to define IRT requirements, which are then configured and validated by the IRT vendor.
IRT is a critical and strategic system that directly affects the speed, quality, and cost of clinical studies. Configuration and validation activities are often on the critical path for study startup.
Accountabilities / Responsibilities
The IRT Specialist will act as an expert and support or replace Clinical Study Supply Leads (CSSLs) in IRT setup and change management. Responsibilities include:
- Help CSSLs translate supply chain design into IRT user requirements
- Support or represent CSSLs in IRT meetings
- Assist or lead risk assessment activities to define UAT (User Acceptance Testing) requirements
- Author and approve test scripts as needed
Additional Responsibilities (as part of the IRT Specialist Network)
- Establish best practices and share issues and lessons learned locally and globally
- Develop and improve IRT processes, SOPs, procedures, and training materials
- Deliver IRT training and guidance to CSSL groups
- Provide general IRT expertise to the broader R&DSC organization
Role Requirements
The IRT Specialist must have:
- Strong technical understanding of business processes and IRT technologies in clinical supply
- Change management capabilities
- Flexibility and adaptability
- Strategic leadership skills
- Commitment to customer focus and integrity
- Strong collaboration skills
The role involves close collaboration with Clinical Study Supply Leads and Study Design Specialists.
Impact
This role directly impacts:
- Speed, quality, cost, and risk of development projects
- Availability of study drug to patients
- Financial and reputational outcomes
Typical Accountabilities
- Act in line with company values, Code of Conduct, and policies
- Complete all required compliance training
- Report any potential non-compliance issues
Global Remit
Education, Qualifications, Skills and Experience
Essential
- In-depth knowledge of R&D Supply Chain and drug development
- Strong understanding of clinical development processes for investigational products
- Demand planning and forecasting experience
- Proficient IT skills across multiple systems
- Strong influencing, negotiation, and problem-solving skills across functions and geographies
- Awareness of GMP and GCP
- Risk identification and management skills
- Excellent written and verbal communication
Desirable
- IRT (RTSM, IxRS) technology experience working for Pharma and/or IRT Vendoe Like Perceptive, Suvoda, Signant Health, 4G Clinical, Endpoint, etc.
- Clinical Supply chain experience - understanding impact and interdependancies within role.
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.