Detail

Salary
negotiable
Location
Macclesfield, UK
Posted by: Astra Zeneca
16 Mar
47 Views
15 May expires

Clinical Study Supply Lead

Macclesfield, UK
Job Description

Would you like to utilise your supply chain knowledge and skill base to lead clinical supplies for your portfolio of global clinical studies? The Clinical Supply Study Lead (CSSL) is a key role within our Clinical Manufacturing and Supply teams. This role involves running a portfolio of studies across all phases of a drug development programme ensuring on time delivery to patients. We have opportunities to join the Clinical Supply Team on either a Permanent Contract, or 12 Month Secondment / Fixed Term Contract, basis.

What you'll do

  • Project manage the delivery of clinical supplies effectively and consistently, and input to the balance of costs and any risks to supply, following defined business processes

  • Lead the Study Drug Working Group and contribute to the Supply Chain Team Meetings enabling continuous cross-functional dialogue with both internal and external partners on study design requirements and associated changes which may impact the supply chain elements of the study

  • Work within GMP Quality Management Systems ensuring that you actively handle any deviations, complaints and change controls

  • Understand customer demand requirements and have the ability to translate this into a supply plan

  • Manage the Interactive Response Technology (IRT) system to execute demand and supply planning

  • Take ownership for Inventory management, utilising systems such as Smart Supplies, including any rework and recalls, extensions of shelf life and expiry date management, or stock destruction

  • Ensure effective communication with project teams and key partners across a global network

  • Support risk management of individual studies with proactive mitigation of risks that potentially impact the quality or delivery of supplies, ensuring consistent on time delivery of drug to patient

  • Monitor the budget for your individual study supply activities and materials for the project including packaging, labelling and distribution costs




Job ID Reference
1476
Desired Skills & Experience
  • Bachelors Degree in a scientific or business subject area – equivalent experience will be considered

  • Experience within a supply chain environment or pharmaceutical industry

  • Holistic knowledge of end to end supply chain activities

  • Experience and proven track record of  successful demand and supply planning

  • Experience in running projects and influencing customer demands

  • Analytical aptitude, showing strong data analysis skillbase and ability to utilise dashboards

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

  • Risk identification and management

  • LEAN capabilities

  • Excellent English written and verbal communication skills

  • Proficient IT skills with an ability to adapt and operate in bespoke multiple systems

 

Desirable Skills & Knowledge

  • Awareness of GMP (Good Manufacturing Practise) and GCP (Good Clinical Practice)

  • Knowledge of clinical development processes relevant to the supply of clinical materials

  • Experienced in handling Quality Events (Deviations, Change Controls, Complaints)

  • Use of either SmartSupplies or SAP would be an advantage

  • Good working knowledge of planning applications

Company
  Gaithersburg, Maryland, USA
  www.astrazeneca.com
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
  Workplace
 Macclesfield, UK