Clinical Supply Study Lead

At AstraZeneca, we put patients first and strive to meet their unmet needs 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.

The Clinical Supply Study Lead (CSSL) designs and executes supply chain for one or more global clinical studies across all phases within drug development. The CSSL holds overall accountability for investigation of product and coordinates associated tasks and activities across all relevant functions within the supply chain. The role will have multiple contacts across internal and external groups including leadership of working groups.

There are key areas of CSSL accountability at the study level:

Study Design influence in relation to drug supply requirements Stakeholder management:

• Lead the Study Drug Working Group and contribute to Supply Chain Team Meetings, to enable continuous cross-functional dialogue with the internal and external stakeholders on the study design requirements and their changes affecting supply chain of the study.
• Lead/contribute to Kick Off Meetings for relevant suppliers (ie pack-label-distribution vendors, clinical CRO, IRT suppliers) and maintain collaboration throughout the study lifecycle
• Escalation of risks / issues / concerns relating to systems and activities through appropriate channels

Demand and Supply - planning and management:

• Development/input to key documents reflecting supply chain design & requirements
• Refined initial and continuous study demand forecasting in order to create a Supply Plan for primary and secondary packing, together with identification of risks related to demand/supply
• Inventory management

Cost management:

• Assessment of projected costs related to packaging, labelling and distribution reflected in supplier Request for Quote
• Control of ongoing study spend and invoice approval
• Flagging risks related to budget constraints to the business

Compliance:

• Management of Quality Events (ie Deviations, CAPAs, Complaints, Change Control)
• Contribution to GMP & GCP audits
• Ensuring eTMF compliance

System utilization:

• IRT
• System used for demand and supply planning
• System used to optimize drug supply design

Packing/labelling/distribution activities:

• Definition and implementation of pack/label/distribution strategy
• Kit/Pack design
• Implementation of Temperature Control and Monitoring strategy
• Master Label development (if relevant)
• Destruction management
• Expiry date management
• Extension of shelf life
• Rework & recalls

Tasks related to the above areas can be supported where appropriate, by relevant Global Clinical Supply Chain supporting functions (Co-Ordinator or Specialists), however the CSSL retains overall accountability for delivery drug supply.

Essential:

• University degree (or equivalent) preferably in medical or biomedical science or discipline associated with clinical research
• Previous relevant clinical trials management or supply chain experience in the pharmaceutical industry
• Knowledge of Clinical Development processes relevant to investigational products
• Awareness of GXP Standards within a Clinical environment
• Project managements and leadership skills, including influencing customer demand
• Ability to adapt and operate in multiple systems
• Strong influencing, negotiating and problem solving skills across geographical/cultural boundaries and various stakeholders
• Demand planning and forecasting experience
• English- fluent written and spoken

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.