- 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
- 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
- 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
- Management of Quality Events (ie Deviations, CAPAs, Complaints, Change Control)
- Contribution to GMP & GCP audits
- Ensuring eTMF compliance
- IRT
- System used for demand and supply planning
- System used to optimize drug supply design
- 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
- University degree (or equivalent) preferably in medical or biomedical science or discipline associated with clinical research
- Previous relevant clinical trials management or supply chain experience in the pharmaceutical industry
- Knowledge of Clinical Development processes relevant to investigational products
- Awareness of GXP Standards within a Clinical environment
- Project managements and leadership skills, including influencing customer demand
- Ability to adapt and operate in multiple systems
- Strong influencing, negotiating and problem solving skills across geographical/cultural boundaries and various stakeholders
- Demand planning and forecasting experience
- English- fluent written and spoken
-
Senior IT Architect
3 dni temu
Boston Consulting Group Warsaw, Polska W pełnym wymiarze godzinDo you want to turn the challenges of digitization into the solutions of the future? Join us in tackling the core IT issues of leading global companies. Deploy customized platforms, architectures, strategies, and organizations to leverage the digital potential of our customers an ...
-
Application Architect
5 dni temu
Connectis Warszawa, PolskaExpected, JavaAbout the project, You will be focused on IT e-Mobility Solutions Architecture, aiming to improve it, extend and ultimately – migrate to the global loyalty architecture concept.Your responsibilities, Understanding business drivers and capabilities, current state and ...
-
Global Project Manager
1 dzień temu
AstraZeneca Warsaw, Polska W pełnym wymiarze godzinAt AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every ...
-
Associate Director Project Manager Country Operations
8 godzin temu
AstraZeneca Warsaw, Polska W pełnym wymiarze godzinAlexion has over 3,000 talented colleagues dedicated to serving people living with rare diseases in more than 50 countries around the world. Our global headquarters are based in Boston, Massachusetts and our EMEA headquarters are in Zürich, Switzerland and Barcelona, Spain. We al ...
-
Senior Clinical Data Scientist
1 tydzień temu
AstraZeneca Warsaw, Polska W pełnym wymiarze godzinCentralised Monitoring (CM) and Centralised Statistical Monitoring (CSM) are a part of Risk-based Quality Management. CM leads work with global and clinical project teams guiding them through the study de-risking exercise, helping to identify areas critical to study quality, as w ...
-
Global Study Manager
3 dni temu
AstraZeneca Warsaw, Polska W pełnym wymiarze godzinGlobal Study Manager is a member of extended global study team supporting delivery of clinical studies within Global Medicines Development (GMD) to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of ...
-
Research Collaboration Study Sr. Associate
6 dni temu
Pfizer Warsaw, Polska W pełnym wymiarze godzinROLE SUMMARY · Research Collaborations (RC) are research studies where Pfizer partners with an external collaborator(s) to develop, conduct and execute research that would be used to support Pfizer business or regulatory goals. The Research Collaboration Study Sr Associate (RCS) ...
-
Manager, Evidence Project Management
1 tydzień temu
AstraZeneca Warsaw, Polska W pełnym wymiarze godzin*** Posion based in Warsaw (hybrid work)*** · Medical Evidence Delivery Team within Oncology Business Unit (OBU) is responsible for strategic planning and operational delivery of interventional and observational AstraZeneca sponsored studies (AZ studies), externally sponsored sc ...
-
Fortrea Warsaw, Polska W pełnym wymiarze godzinAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and techn ...
-
Ergomed Warsaw, Polska W pełnym wymiarze godzinJob Description · We are looking for someone who can speak German · Provides Study Start-Up Specialist activities in support of assigned projects including regulatory submissions, informed consent review, site contract/budget negotiation, essential document collection and revi ...
-
Associate Director, Risk based Quality Management
1 dzień temu
AstraZeneca Warsaw, Polska W pełnym wymiarze godzinABOUT ASTRAZENECA · At AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide. Our purpose is results- ...
-
Project Director
1 dzień temu
Innovaderm Research Warsaw, Polska PermanentThe Project Director is responsible for oversight of the conduct of a program or portfolio of clinical studies or large global multicentered trials with large study budgets. The portfolio may comprise studies for specific customers, and/or a group of studies within the same thera ...
-
AstraZeneca Warsaw, Polska W pełnym wymiarze godzinAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical ...
-
Ergomed Warsaw, Polska W pełnym wymiarze godzinJob Description · We are looking for someone who can speak German · Provides Study Start-Up Specialist activities in support of assigned projects including regulatory submissions, informed consent review, site contract/budget negotiation, essential document collection and review ...
-
RWE Associate Site Manager
2 dni temu
IQVIA Warsaw, Polska W pełnym wymiarze godzinAssociate Site Manager with French Real-World Evidence · Hybrid: EMEA · Join us on our exciting journey · IQVIA Real-World Evidence (RWE) teams work with clients to help them collect and use real-world data to generate evidence to meet the needs of regulators, payers, provide ...
-
Application Architect @
17 minut temu
Connectis_ Warsaw, Polska W pełnym wymiarze godzinYou will be focused on IT e-Mobility Solutions Architecture, aiming to improve it, extend and ultimately - migrate to the global loyalty architecture concept. · We Offer: Long-term collaboration perspective on exciting projects 5000 zł for each recommended Specialist for our proj ...
-
Senior Product Manager
12 godzin temu
Allegro -, Warszawa, Polska W pełnym wymiarze godzinJob Description · Depending on your annual assessment and the company's results we offer: · Annual bonus up to 20% of the annual salary gross · Long-term discretionary incentive plan based on shares · A hybrid work model requires 3 days a week in the office. · We are looking fo ...
-
Global Development Scientist Director Late Oncology
1 tydzień temu
AstraZeneca Warsaw, Polska W pełnym wymiarze godzinAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. · Recognizing the importance of ind ...
-
Clinical Team Lead II
1 dzień temu
Rho Warsaw, PolskaOverview · Join us in redefining what it means to work for a CRO. Working at Rho, you'll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity's biggest challenges. · At Rho, ...
-
Associate Director, Evidence Project Management I, II
1 tydzień temu
AstraZeneca Warsaw, Polska W pełnym wymiarze godzinDescription · of Services) · • Co-ordinate/manage timely contributions of AZ core/extended members · • Interface with key stakeholders cross-functionally, and/or external partners, to identify, manage and resolve issues affecting study delivery · • Review protocol drafts and inp ...
Clinical Supply Study Lead - Warsaw, Polska - AstraZeneca
Opis
Clinical Supply Study Lead
Hybrid work: 3 days from the office, 2 days from home
ABOUT ASTRAZENECAThe 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:
Demand and Supply - planning and management:
Cost management:
Compliance:
System utilization:
Packing/labelling/distribution activities:
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.
Essential:
Why AstraZeneca?
Date Posted
04-Apr-2024Closing Date
31-May-2024
