Study Manager

hace 5 meses

Barcelona, España AstraZeneca A tiempo completo

**Location: Barcelona**

Join our Biopharmaceuticals R&D team as a Study Manager, where you will provide oversight for Study Supply Management activities, coordinating across supply functions within the LCS matrix. You will independently plan, handle and deliver all aspects of Investigational Medicinal Product (IMP) supply for assigned clinical studies. This role requires collaboration within Logistics and Clinical Supply (LCS), and with all other interfaces and team members internally and externally as required to ensure highly effective clinical supply planning and execution.

**Typical Accountabilities**:

- 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 appro

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