Clinical Supply Study Lead

ABOUT THE ROLE

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. 

Typical accountabilities

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: SSSD (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 related to demand/supply 

• Demand and supply efficient change management 

• Inventory management 

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 Visual Management meetings according to SCQS (SHE, cost, quality, supply) priorities 

• Ensuring eTMF compliance 

• OOD reporting 

System utilization: 

• IRT 

• Smart Supplies platform 

• The 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 

Skills, Experience, Education

Essential:

 - Knowledge of Supply chain and drug development process. 

 - Awareness of GXP Standards within a Clinical environment 

- Demand planning and forecasting experience 

- Experience of managing projects and influencing customer demands 

- Proficcient IT skills with an ability to adapt and operate in multiple systems 

- Strong influencing, negotiating and problem solving skills across geographical and cultural boundaries 

Desirable:

- 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 

What we offer

Welcome to Warsaw Site, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day.

To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you:

• The best team to support you
• Multisport card
• Pension plan
• Life insurance
• After-work events
• Private medical care
• Lunch card
• Bright and spacious environment
• Sustainable office working environment.

Please note that we are working in a hybrid model of 3 days per week from the office in Warsaw

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.