The Senior Clinical Supply Study Lead (sCSSL) design and execute optimized supply chains for complex global clinical studies across all phases within drug development.  

The SCSSL holds the overall responsibility for delivery of IP to a specific study and co-ordinate associated tasks and activities across all relevant functions supporting the supply. Senior CSSL is expected to have a good understanding of planning best practice and to demonstrate proficiency in supply planning systems. The sCSSL have multiple contacts across internal and external groups including leadership of working groups. Beyond managing supply to studies, the sCSSL also provide mentoring and support to already experienced colleagues and drive improvements and processes in the Clinical Study Supply area.  

Key responsibilities for role: 

•  Execute study delivery, following planning processes to optimise service, waste and cost impact. 

• Mentor, support and coach already experienced CSSLs managing complex and demanding clinical studies to setup and execute supply in an optimized way. 

• Lead or be a key contributor in business development projects or initiatives. Especially in the areas of supply chain excellence, digital capability and drive the implementation of this in the CSSL community 

• The Senior Clinical Supply Study Lead can be a business process owner for a defined supply chain process. 

• Drive improvement initiatives 

• Identify, manage, and mitigate risks in studies and the business area 

• Act and promote according to Lean Leadership Habits and Behaviours   

While managing supply to a study the responsibilities are: 
 

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 N-Side 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: SSSD (or equivalent), SDPA, PSF 

• Refined initial and continuous study demand forecasting in order to create a Supply Plan for secondary packing, together with identification of risks related to supply 

• Efficient execution of change management (ie label changes or expiry switches) 

• Inventory management, leading to waste reduction 

Cost management: 

• Assessment of projected costs related to packaging, labelling and distribution In line with AQIRE 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 TIER meetings according to SQSCP (SHE, quality, supply,cost, people) priorities  

• Ensuring eTMF compliance 

• OOD reporting 

 System utilization: 

• IRT 

• Smart Supplies platform 

• The N-Side Suite  

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 sCSSL retains overall responsibility for delivery of study drug. 

• Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products. 

• Knowledge of Clinical Development processes 

• relevant to investigational products. Lean experience/qualifications 

• >2 years’ CSSL experience