Oferta pracy

Clinical Supply Study Lead - Clinical Trials

AstraZeneca Pharma

  • Lubicz 23a, Grzegórzki, Kraków
    Kraków, Lesser Poland
  • valid for 24 days
    until: 12 Jun 2022
  • contract of employment
  • full-time
  • specialist (Mid / Regular)
  • remote recruitment
  • запрошуємо працівників з України
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Запрошуємо працівників з України
Роботодавець відкритий для працевлаштування громадян України

AstraZeneca Pharma

Lubicz 23a

Grzegórzki

Kraków

Your responsibilities

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

Our requirements

Tasks related to the above areas can be supported where appropriate, by relevant Global Clinical Supply Chain supporting functions (Co-Ordinator or Specialists), however the CSSL retains overall accountability for delivery drug supply.

What we offer

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

  • Benefits

  • sharing the costs of sports activities

  • private medical care

  • sharing the costs of foreign language classes

  • sharing the costs of professional training & courses

  • life insurance

  • remote work opportunities

  • flexible working time

  • fruits

  • integration events

  • corporate gym

  • corporate car available for private use

  • retirement pension plan

  • corporate credit card

  • video games at work

  • coffee / tea

  • drinks

  • parking space for employees

  • leisure zone

  • meal passes

  • sharing the costs of tourist services

  • holiday funds

  • sharing the costs of holidays for kids

  • christmas gifts

  • employee referral program

  • opportunity to obtain permits and licenses

  • charity initiatives

  • extra leave

  • annual bonus

  • glasses reimbursement

  • business travel insurance

  • Work anniversary award

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Where can I find out more?

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

AstraZeneca Pharma

ABOUT ASTRAZENECA

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

SITE DESCRIPTION

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.

What you can expect: great working atmosphere empowering you to reach your full potential, endless development opportunities and benefits like: medical & life insurance, lunch card, annual bonus, education cost reimbursement, occasional allowances (Christmas, holiday), Multisport, anniversary awards, additional time off, pension plan, business travel insurance, recognition programme, flexible working hours.

At AstraZeneca, every one of our employees makes a difference to patient lives every day.

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This is how we work