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Study Manager - Logistics and Clinical Supply

地点 劍橋, 英格兰, 英国 职位 ID R-065842 发布日期 11/14/2019

AstraZeneca is a global, creative, biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AZ, we're proud to have an outstanding workplace culture that encourages innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energised and rewarded for their ideas and creativity.

Summary

As Study Manager, you will be responsible for independently planning, managing and delivering IMP supply for clinical studies that are assigned. The Study Manager will typically balance the management of multiple studies involving diverse development compounds. Studies may be internally or externally sponsored, domestic or international in scope and may include complex operations such as associated with later phase clinical trials, or include the provision of Auxiliary Medicinal Products (AMP).

Major Duties and Responsibilities

  • Use defined tools and procedures to create documentation required to support IMP supply
  • Provide input into all relevant study related documents
  • Maintain IMP study documentation in defined document repositories, as appropriate for GXP purposes, e.g., Trial Master File (TMF)
  • Ensure all documentation is appropriately filed and is up-to-date, accurate, complete and delivered promptly
  • Ensure  necessary IMP related documentation is available to the Product Specification File
  • Support the oversight of the activities related to processing of product complaints, non-conformances, product recalls or inquiries pertaining to IMP received from clinical sites, depots or couriers
  • Build or assist in the creation of SOPs, systems and processes to support improvement and future growth of LCS and Study Management standard methodology
  • Cooperate effectively within LCS to provide close coordination of Vendor, Distribution and Systems Management activities for assigned projects
  • Generate, develop and maintain LCS agreed clinical supply strategies for IMP
  • Plan and lead regular LCS Matrix Team meetings. Agree to scope of work, and implement detailed plans and timelines with Systems, Distribution, and Vendor Management representatives and collaborate to achieve agreed supply activities
  • Enact immediate responses to changes in supply remit and ensure LCS review and timely resolution of issues and challenges as they arise
  • As a member of the Supply Continuity Team (SCT), provide to and influence the development/supply scheme for studies, ensuring that risks/opportunities for supply optimization are discussed
  • Communicate within Smart Supplies Forecasting a dynamic project demand forecast for assigned clinical studies
  • Liaise closely to ensure clear transfer of information to the Vendor Manager responsible for creation and management of the study budget
  • Represent LCS as an engaged and agile participant at the Clinical Trial Team (CTT). Ensure good information exchange in relation to current supply activities, influence for effective and timely consideration of any change scenarios that may impact supply plans
  • Support actively the SCT to align planning and implementation of any agreed changes
  • Maintain and expand close cross-functional relationships to support and enable activities regarding IMP release. (e.g. kit activation and confirmation of release in the LCS systems)
  • Liaise closely with Quality Assurance (QA) to ensure that all activities are conducted in accordance with cGMP, GCP, & ICH guidelines
  • Partner with stakeholder departments to identify critical challenges and risks associated with IMP supply to the clinic. Communicate and provide input into risk management plans including options and recommendations for risk mitigation
  • Attend and actively participate in departmental meetings
  • Participate where required in LCS departmental and/or assigned cross-functional process improvement initiatives
  • Apply training and expertise to deliver against flexible assignments within other aligned LCS roles as required
  • Mentor, develop and generally supervise the daily activities of other members of staff (members of LCS, MEDImatch, etc.) assigned to flexible roles within the Study Management team, or assigned as support staff to partner in delivery of more complex study assignments.
  • Communicate with assigned teams, BPD, and with all interfacing functions and relevant groups as required

Qualifications

  • Education Bachelor's degree in basic/applied science or engineering
  • Equivalent level of training in service may also be considered

Experience

  • 8+ years experience in planning and delivering all aspects of IMP management for clinical studies, including oversight of vendors managing GMP operations
  • Good understanding of cGMP, GCP and ICH guidelines as related to IMP management
  • Experience in the Biotechnology and/or Pharmaceutical industry is required
  • Preferably will have a sound understanding of the drug development process and ideally also have demonstrable success in delivering cross-functional projects and/or activities
  • Ability to work in a dynamic environment and collaborate effectively within diverse teams to deliver complex projects


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 authorisation and employment eligibility verification requirements.

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