Clinical Supply Study Lead

Job Title: Clinical Supply Study Lead 
Location: Warsaw, Poland
Work model: Hybrid (3 days from office per week)

About AstraZeneca
At AstraZeneca, we are guided by our purpose to push the boundaries of science to deliver life-changing medicines. We combine innovation with integrity, operating to the highest standards of quality and compliance. We foster an inclusive, diverse, and collaborative culture where everyone feels empowered to make a meaningful impact for patients, customers, and society.

Role Overview

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.

Key Responsibilities

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

1)      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.

2)      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

3)      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 related to demand/supply.

• Demand and supply efficient change management.

• Inventory management.

4)      Cost management:

• Assessment of projected costs related to packaging, labelling and distribution In line with SAMPA process.

• Control of ongoing study spend via PO and invoice approval.

• Flagging risks related to budget constraints via SCT

5)      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

6)      System Utilisation

• IRT

• Smart Supplies platform

• The N-Side Suite(former CT-Fast)

7)      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

Required Qualifications

• Education: Bachelor’s degree or equivalent experience in Business, Administration, Languages, or related field.

• Experience: 1–3 years in customer service, service desk, shared services, or operations within a multinational environment.

• Technical Skills: Proficiency with CRM/ticketing tools (e.g., ServiceNow, Salesforce) and MS Office 365; strong data entry accuracy and attention to detail.

• Communication: Fluency in English (written and spoken); strong interpersonal skills with ability to communicate clearly and professionally across cultures and levels.

• Problem Solving: Proven ability to analyze issues, prioritize workload, and follow through to resolution under time pressure.

• Compliance Mindset: Demonstrated understanding of quality, privacy, and information security principles.

Preferred Qualifications

• Additional language skills: Polish.

• Experience in pharmaceutical, life sciences, or regulated industries.

• Familiarity with process improvement methodologies (Lean, Six Sigma) and knowledge base management.

• Experience supporting global stakeholders across time zones.

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.