Associate Study Manager, Logistics & Clinical Supply (LCS)

Gaithersburg, Maryland

Posted in Pharmaceuticals
28 days ago

Job Description

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration through scientific research. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

Location: Gaithersburg, MD or Granta Park, UK

Position Summary

Plan and Manage Investigational Product (IMP) supply for assigned clinical studies. Work collaboratively within Logistics and Clinical Supply (LCS) to ensure seamless delivery by LCS Matrix team (Study, Vendor, Distribution and Systems management activities). Liaise with interfaces and stakeholders internally and externally as required to ensure highly effective clinical supply planning and execution, including on-going responsiveness to any changes that may impact supply strategy. Contribute to the operational effectiveness of Logistics and Clinical Supply.

Key Responsibilities

- Plan and manage IMP supply for assigned clinical studies. The Associate Study Manager/Study Manager will typically be responsible for management of a number of clinical studies which may include a portfolio of External Sponsored Research studies (ESR) and may involve a few different development compounds. Studies may be domestic and /or international in scope and may be in clinical development Phase 1 or 2.

Using defined tools and procedures create documentation required to support IMP supply activities

- Provide LCS input into all relevant study related documents and Maintain IMP study documentation in defined document repositories, as appropriate for both GMP and GCP purposes. Ensure all documentation is appropriately filed in a timely manner and is current, accurate and complete and delivered according to agreed timelines.

Ensure necessary IMP related documentation is available to the Product Specification File.

Maintain oversight of the activities related to processing of IMP product complaints, non-conformances, product recalls or inquiries pertaining to assigned clinical studies

As required, provide support to enable planning and management of more complex (e.g. later stage) clinical studies, working together with Technical Manager or other assigned Study Manager or Senior Manager within LCS

- Assist in the review and preparation of departmental SOPs, systems and processes to support maintenance, improvement and future growth of Study Management best practice

Collaborate effectively within LCS to provide close coordination of LCS Matrix team (Study, Vendor, Distribution and Systems management activities) for assigned projects.

Create, develop and maintain LCS agreed clinical supply strategy for IMP

Plan and lead regular LCS Matrix meetings. Agree scope of work, and more detailed plans and timelines with Systems, Distribution, and Vendor Management representatives and collaborate to achieve agreed supply activities

- Collaborate in ensuring responsiveness 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) contribute to and influence the development /supply strategy for assigned studies, ensuring that the demand, risks and opportunities for supply optimization are taken into account

- Create, maintain and communicate within Smart Supplies Forecasting a dynamic project demand forecast for assigned clinical compounds/studies

Represent LCS as an engaged and active 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, and ensure dynamic interface with the SCT to align planning and implementation of any agreed changes

Build relationships with cross-functional groups to support and enable activities associated with IMP release. This includes activities such as kit activation and confirmation of release in the appropriate study systems

- Liaise closely with Quality Assurance (QA) to ensure that all Study Management activities are conducted in accordance with cGMP, GCP, & ICH guidelines

US Requirements/Qualifications

  • Minimum of a Bachelor's degree in basic or applied science or engineering, or equivalent level of training (4+ years) in service in lieu of a degree.
  • BS and 5+ years relevant experience (or 9+ years of experience in lieu of BS)
  • MS and 3+ years relevant experience
  • Direct experience working in a development or technical operations environment in the pharmaceutical, scientific or health care product industry.

UK Requirements/Qualifications

Requires a Bachelor's degree in basic / applied science or engineering. Equivalent level of training in service may also be considered. The Associate Study Manager will have appropriate direct experience working in a development or technical operations environment in the pharmaceutical, scientific or health care product industry. Specific experience in IMP management and/or supply is desirable.

  • Experience in planning and delivering all aspects of IMP management for clinical studies, ideally including oversight of vendors managing GMP operations. A 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 demonstrable success in delivery of cross-functional projects and/or activities
  • Ability to work in a dynamic environment and collaborate effectively within cross functional teams to deliver complex projects

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