Clinical Supply IRT specialist
ABOUT ASTRAZENECA
Every one of our employees makes a difference to patient lives every day. You may not feel you’re at the frontline of research but your role in changing patients’ lives is critical. Our mission is ambitious, and it takes the skills of a collaborative team to really deliver on what science can do and to always put patients first. Working at AstraZeneca we believe in the potential of our people and our commitment to develop our people beyond what was thought possible.
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.
Accountabilities / Responsibilities
This document defines all responsibilities an Clinical Supply IRT Specialist could undertake – the responsibilities to be performed in a calendar year will be identified in the goals and objectives for that year.
The Clinical Supply IRT Specialist is accountable for delivering the GCSC inputs to the onboarding and Continuous Improvement of IRT Standards and studies which can include but is not limited to:
- Inputting to and completing Technical Standards documentation both standards and studies
- Completing Risk Assessment both standards and studies
- Author/approve test scripts as required – both standards and studies
- Develop and deliver training material on standards
- Create internal SOP’s to document and define process
- Represent Global Clinical Supply Chain in governance interactions, both internal and external
The Clinical Supply IRT Specialist will act as a role model and expert consultant to IRT Specialists and within both GCSC and Clinical Operations, which involves:
- Drives and role models excellence in delivery in IRT Set up and change management and associated values and behaviours and develops excellence in others through their interactions with them.
The Clinical Supply IRT Specialistis also accountable for the leading projects to develop future solutions and to innovate to meet the challenges of the future supply chain, for example, Direct to patient in IRT projects, JIT, pooling or other novel innovations. 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.
Essentials:
- In depth knowledge of R&D Supply Chain and drug development process.
- In depth knowledge of Clinical Development processes relevant to investigational products.
- In depth knowledge of IRT systems and interactions
- 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 communcation skills
What we offer:
Welcome to Warsaw Site, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day.
To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you:
The best team to support you,
Multisport card,
Pension plan,
Life insurance,
after-work events,
private medical care
lunch card,
bright and spacious environment,
sustainable office working environment.
Please note that we are working in a hybrid model of 3 days per week from the office in Warsaw