Role – Clinical Study Supply Lead
Location – Macclesfield, UK (3 days per week on-site hybrid working)
Duration – 12 months
IR35 Status – Inside
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 delivery of IP and co-ordinates 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:
- Input to Study Design Concept, Clinical Study Protocol, Handling Instructions, Pharmacy Manual or other relevant.
- Works in collaboration with the Design specialist and IRT specialist teams to agree optimum SC design using the Suite (former CT-Fast) where applicable to optimize IRT settings.
- Input to randomization strategy.
Stakeholder management:
- Lead the Study Drug Working Group to enable continuous dialogue with the clinical team on the study design requirements and their changes affecting supply chain of the study.
- Contribution to the Supply Chain Team Meetings, ensuring effective collaboration with Dev QA, Analytical, CMC, SCPL & Clinical partners (and other, if relevant)
- Lead/contribute to Kick Off Meetings for relevant suppliers (ie PLD, clinical CRO, IRT) and maintain collaboration throughout the study lifecycle.
- Escalation of risks / issues / concerns relating to systems and activities through appropriate channels
- Support of specified activities in outsourced studies and partnership with CSOS colleagues.
- Support knowledge sharing and creating great place to work environment among peers across whole Global Clinical Supply Chain
Demand and Supply – planning and management:
- Development/input to key documents reflecting supply chain design & requirements: CAA (or equivalent), SDPA, PSF
- Refined initial and continuous study demand forecasting in order to create a Supply Plan for primary and secondary packing, together with identification of risks relatedto demand/supply.
- Demand and supply efficient change management.
- Inventory management.
Cost management:
- Assessment of projected costs related to packaging, labellingand distribution In line with SAMPA process.
- Control of ongoing study spend via PO and invoice approval.
- Flagging risks related to budget constraints via SCT
Compliance:
- Management of Quality Events (ie Deviations, CAPAs, Complaints, Change Control)
- Contribution to GMP & GCP audits
- Provide regular update during Visual Management meetings according to SCQS (SHE, cost, quality, supply) priorities
- Ensuring eTMF compliance
- OOD reporting
System Utilisation
- IRT
- Smart Supplies platform
- The N-Side Suite(former CT-Fast)
Packing/labelling/distribution activities
- Definition and implementation of PLD strategy
- Kit/Pack design
- Implementation of TCM and management of the 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 (CSC or CSSL), however the CSSL retains overall responsibility for delivery of study drug.
Why AstraZeneca
At AstraZeneca, we are driven by science and committed to delivering meaningful outcomes for patients. Based in Macclesfield, you will be part of a vibrant scientific and supply chain community , working alongside colleagues who are passionate about advancing new medicines and improving outcomes for patients.
…