Clinical Supply IRT Specialist
AstraZeneca
Cambridge, United Kingdom
4d ago

Clinical Supply IRT Specialist

12 month - secondment / FTO or Fixed term contract

Global Clinical Supply Chain

At AstraZeneca, we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide.

Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Pharmaceutical Technology and Development (PT&D) is the bridge which turns forward-thinking science into actual medicines that help millions of people.

We work across the entire value chain, designing and delivering active ingredients, formulations and devices required to support new medicines from supplies for use in clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

Description

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

The IRT Specialist will act as expert and support / replace Clinical Study Supply Leads in IRT set-up and change management : This will include :

  • We need you to 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 the need arises
  • In addition, as part of a wider IRT Specialist Network, contribute to :

  • Establishing standard methodology 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 organisation 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

    Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.

    Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.

    Essential

    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.

    AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.

    We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.

    We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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