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Study Manager

hace 3 semanas

Barcelona, España AstraZeneca A tiempo completo

**About AstraZeneca**

AstraZeneca is a global, science-led, patient-centric biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines. Join the team dedicated to BioPharmaceutical Development.

**About the role**
- Provides oversight for Study Supply Management activities, coordinating across supply functions within the LCS matrix.
- Independently plans, manages and delivers all aspects of Investigational Medicinal Product (IMP) supply for assigned clinical studies.
- Works collaboratively within Logistics and Clinical Supply (LCS), and with all other interfaces and stakeholders internally and externally as required to ensure highly effective clinical supply planning and execution.
- Uses experience to develop supply strategies, and influences to ensure that any issues are appropriately managed such that Biopharmaceutical Development (BPD) project goals and milestones are seamlessly achieved.
- Develops and follows functional policies and best practices.
- Contributes to the operational effectiveness of LCS.

**Responsibilities**:

- Works within a matrix team to plan, manage 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 included:

- Using defined tools and procedures to create documentation 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 the 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 manage dynamic project demand forecasts and production planning for assigned clinical studies.
- Liaises closely with relevant teams and suppliers regarding the delivery of materials.
- Communicates to ensure clear transfer of information to the Vendor Manager responsible for the 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. Escalates issues to more senior employees 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.
- Manages 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.

**Essential for the role**
- Bachelor's degree in basic/applied science or engineering. Equivalent level of training in service may be considered.
- Stakeholder management in a customer-facing role.
- Direct Experience in a Development o