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

Relevant experience and qualifications relating to the above.