Study Supply Management

• Works within a matrix team to plan, run and deliver IMP supply for assigned clinical studies.  The Study Manager will typically be responsible for achieving operational and technical delivery against defined supply and quality targets. Studies may be AstraZeneca or externally sponsored, domestic or international in scope.  Activities include:
  • Using defined tools and procedures to catalogue required to support IMP supply.
  • Providing input into relevant study related documents.
  • Maintaining IMP study documentation in defined document repositories, as appropriate for GXP purposes e.g., Trial Master File (TMF). Ensuring all documentation is appropriately filed and is current, accurate, complete and delivered according to agreed timelines.
  • Ensuring necessary IMP related documentation is available to service the Product Specification File.
  • Maintaining 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.

• Collaborates 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 plan for IMP.
  • Leads regular LCS Matrix Team meetings.  Coordinates 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.
• Creates, maintains and communicates within Smart Supplies Forecasting and Planning to handle dynamic project demand forecasts and production planning for assigned clinical studies.
• Liaises closely with relevant teams and suppliers regarding delivery of materials
• Communicates to ensure clear transfer of information to the Vendor Manager responsible for creation and management of the study budget.

• Where appropriate, represents LCS as an engaged and active participant at the Clinical Trial Team (CTT).  Ensures good information exchange in relation to current supply timelines, collaborates for effective and timely consideration of any scenario planning which may impact supply plans, and provides feedback to the Supply Continuity Team (SCT) to align planning and implementation of any agreed changes

• Develops close cross-functional relationships to support and enable activities associated with IMP release, such as confirmation of release in the appropriate LCS systems; internal and external.
• Liaises closely with Quality Assurance (QA) to ensure that all Study Management activities are conducted in accordance with cGMP, GCP, & ICH guidelines.
• Resolves routine issues in partnership with key interfacing roles to ensure supply continuity.  Raises issues to more senior emplyees where necessary.

• Communicates and provides input into risk management plans.
• Attends and actively participates in departmental meetings.
• Develops and streamlines processes within own team or area.  May participate where required in LCS departmental process improvement initiatives.

• Leads the reconciliation and destruction of DP/IMP supplies for study close-out, and maintains internal and external inventory systems to reflect accurate inventory counts
• Mentor, develop and generally supervise the activities of other members of co-workers (LCS staff, summer interns, rotational associates  etc.) assigned to flexible roles within the Distribution team

Typical Accountabilities (per AZ framework and regulatory expectations):

• Owns delivery of clinical study supply for assigned clinical studies. 
• Undertakes operational and tactical planning and ensures execution of plans in order to deliver against business requirements in a professional and efficient manner
• Undertakes process planning, communicates objectives and monitors performance to ensure delivery against agreed targets
• Undertakes reporting via both information systems and paper-based systems
• Monitors and maintains compliance to current current cGMP, GDP, GCP, & ICH guidelines, raising and addressing problems as they arise
• Develops and follows policies and procedures in execution of activities
• Communicates and aligns to ensure appropriate quality service delivery and appropriately increases within the Study Management funtion where issues threaten delivery
• Optimises performance outcomes of cross functional teams and ensures individuals understand the contribution they make
• Acts as point of contact to third party suppliers providing services to AZ – chiefly manufacturing suppliers.
• Promotes continuous improvement, identifying and delivering performance improvements
• Works independently under general supervision.  Expected to seamlessly follow and train against agreed processes and SOPs, and independently determine and develop approaches to technical issues.  Work is monitored for technical judgement and achievement.

Education, Qualifications, Skills and Experience

Essential:

• Bachelors degree in basic/applied science or engingeering.  Equivalent level of training in service may be considered
• Stakeholder management in a customer facing role, partnering to achieve objectives
• Direct Experience in a Development or Technical Opearations environment in the pharmaceutical, scientific or health care industry. 
• Working knowledge of challenges in delivery of international clinical studies, with focus on IMP supply & management
• A good understanding of cGMP, GCP and ICH guidelines as related to IMP management, and a sound understanding of the drug development process
• Ability to work in a dynamic environment, and collaborate effectively within cross functional teams to deliver complex projects
• Experience managing delivery of complext prlects through internal or external suppliers / cross functional teams
• Highly organised teamworker with excellent attention to detail and strong communication skills
• Strong analytical skills, excellent attention to detail and interest in technical troubleshooting.
• IT proficiency appropriate to a systems driven manufacturing role

Desirable:

• Change responsive
• Influencing and negotiation skills.
• Process development / process management experience
• Management skills appropriate to an effective mentor
• Experience in IMP management
• Oversight of vendors performing GMP operations

At AstraZeneca, we follow the science to explore and innovate. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Are you ready to join a team unlocking the power of what science can do? Are you driven by your desire to understand and reveal new insights? If your passion is science and you want to be part of a team that makes a bigger impact on patients' lives, then there's no better place to be. Apply now!