Manager, LCS Study Management

Cambridge, UK

Salary & Benefits Competitive

Diverse Minds. Bold Disruptors. Meaningful Impact.

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

With colleagues from 70 countries across our UK sites, you’ll find your voice in an inclusive and diverse community. Our Cambridge hub is high on the target list of international destinations to work and stacked with globally important roles.

The setup: An exciting bioscience hotspot, Cambridge is home to one of AstraZeneca’s three strategic, global R&D Centres, alongside Gothenburg and Gaithersburg. Over 3,600 employees are based in Cambridge. Our offices are internationally renowned for attracting high performers, including several Nobel prize winners.

Be part of a dedicated Research & Development team. Fuelled by our commitment to help more patients, strengthen our pipeline and grow our area.

Typical Accountabilities

• Independently plan, manage and deliver IMP supply for assigned clinical studies.  The Study Manager will typically be responsible for management of multiple studies involving diverse development compounds. Studies may be AstraZeneca or externally sponsored, domestic or international in scope and may include complex operations such as associated with later phase clinical trials, or in the provision of Auxiliary Medicinal Products (AMP).
  • Using defined tools and procedures 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 current, accurate, complete and delivered according to agreed timelines.
  • Ensure necessary IMP related documentation is available to service the Product Specification File.
  • Maintain 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.

• Create, or assist in the creation of departmental SOPs, systems and processes to support improvement and future growth of LCS and Study Management best practice.
• Collaborate effectively within LCS to provide close coordination of 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 Team meetings.  Coordinate on 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 risks / opportunities for supply optimization are discussed.
• Create, maintain and communicate within Smart Supplies Forecasting and Planning to manage dynamic project demand forecasts and production planning 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 active participant at the Clinical Trial Team (CTT).  Ensure good information exchange in relation to current supply activities, influence the team 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.
• Maintain and expand close cross-functional relationships to support and enable activities associated with IMP release.  This includes activities such as kit activation and confirmation of release in the appropriate LCS systems.
• Liaise closely with Quality Assurance (QA) to ensure that all Study Management 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 own 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 assigned to flexible roles within the LCS team, or assigned as support staff to partner in delivery of more complex study assignments.
• Communicate effectively with assigned teams, BPD, and with all interfacing functions and relevant groups as required

Education, Qualifications, Skills and Experience

Essential

• Bachelor’s degree in basic / applied science or engineering.  Equivalent level of training in service may also be considered.
• Knowledge of Pharmaceutical production supply chain principles, Good Manufacturing Practice, Food and Drug Administration requirements (or equivalent), Customs rules and regulations

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.

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

So, what’s next?

Complete your application before the below closing date.

This role is open from 02/09/2021 and welcome with your application no later than 16/09/2021

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

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Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.