Empleos actuales relacionados con Study Manager - Barcelona, Barcelona - AstraZeneca

  • Clinical Operations Lead

    hace 2 semanas

    Barcelona, Barcelona, España Empresa reconocida A tiempo completo

    Job DescriptionWe are seeking a highly skilled Clinical Operations Lead to join our team at Empresa reconocida. As a key member of our operations team, you will be responsible for overseeing the delivery of Site Management project tasks and ensuring overall project efficiency.Key Responsibilities:Project Oversight: Provide guidance and advice to achieve high...

  • Clinical Operations Lead

    hace 2 semanas

    Barcelona, Barcelona, España Empresa reconocida A tiempo completo

    Job DescriptionWe are seeking a highly skilled Clinical Operations Lead to join our team at Empresa reconocida. As a key member of our operations team, you will be responsible for overseeing the delivery of Site Management project tasks and ensuring overall project efficiency.Key Responsibilities:Project Oversight: Provide guidance and advice to achieve high...

  • Medical Research Project Manager

    hace 2 semanas

    Barcelona, Barcelona, España Bayer (Schweiz) Ag A tiempo completo

    Job SummaryBayer (Schweiz) Ag is seeking a highly skilled Medical Research Project Manager to lead and manage all aspects of assigned medical research projects. The successful candidate will be responsible for ensuring successful delivery on study objectives, collaborating with internal stakeholders, and promoting a sense of urgency to deliver results.Key...

  • Medical Research Project Manager

    hace 2 semanas

    Barcelona, Barcelona, España Bayer (Schweiz) Ag A tiempo completo

    Job SummaryBayer (Schweiz) Ag is seeking a highly skilled Medical Research Project Manager to lead and manage all aspects of assigned medical research projects. The successful candidate will be responsible for ensuring successful delivery on study objectives, collaborating with internal stakeholders, and promoting a sense of urgency to deliver results.Key...

  • Clinical Project Manager

    hace 2 semanas

    Barcelona, Barcelona, España Empresa reconocida A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Project Manager to join our Global Clinical Operations team at Empresa reconocida. As a key member of our team, you will be responsible for overseeing the execution of clinical trials, ensuring timely delivery, and maintaining high-quality standards.Key ResponsibilitiesStudy Execution Planning:...

  • Clinical Project Manager

    hace 3 semanas

    Barcelona, Barcelona, España Empresa reconocida A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Project Manager to join our Global Clinical Operations team at Empresa reconocida. As a key member of our team, you will be responsible for overseeing the execution of clinical trials, ensuring timely delivery, and maintaining high-quality standards.Key ResponsibilitiesStudy Execution Planning:...

  • Clinical Project Manager

    hace 2 semanas

    Barcelona, Barcelona, España Empresa reconocida A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Project Manager to join our Global Clinical Operations team at Empresa reconocida. As a key member of our team, you will be responsible for overseeing the execution of clinical trials, ensuring timely delivery, and maintaining high-quality standards.Key ResponsibilitiesStudy Execution Planning:...

  • Clinical Project Manager

    hace 3 semanas

    Barcelona, Barcelona, España Empresa reconocida A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Project Manager to join our Global Clinical Operations team at Empresa reconocida. As a key member of our team, you will be responsible for overseeing the execution of clinical trials, ensuring timely delivery, and maintaining high-quality standards.Key ResponsibilitiesStudy Execution Planning:...

  • Senior Project Manager

    hace 2 semanas

    Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completo

    **Job Summary**At Thermo Fisher Scientific, we are seeking a highly skilled and experienced Senior Project Manager to join our team. As a key member of our organization, you will be responsible for leading and coordinating the execution of clinical trials from start-up through database close and inspection readiness.**Key Responsibilities**Provide quality...

  • Clinical Project Manager

    hace 5 días

    Barcelona, Barcelona, España Empresa Reconocida A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Project Manager to join our Global Clinical Operations team. As a key member of our team, you will be responsible for ensuring the successful execution of clinical trials across various countries and regions.Key ResponsibilitiesSupport the development of country/cluster/hub study execution plans and...

  • Clinical Project Manager

    hace 4 días

    Barcelona, Barcelona, España Empresa Reconocida A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Project Manager to join our Global Clinical Operations team. As a key member of our team, you will be responsible for ensuring the successful execution of clinical trials across various countries and regions.Key ResponsibilitiesSupport the development of country/cluster/hub study execution plans and...

  • Clinical Project Manager

    hace 2 semanas

    Barcelona, Barcelona, España Syneos Health, Inc. A tiempo completo

    About the Role**Job Summary**We are seeking an experienced Clinical Project Manager to join our team at Syneos Health, Inc. as a Sponsor Dedicated Clinical Project Manager. This is a home-based position in Spain, and we are looking for a professional with a strong background in clinical project management on global studies.Key Responsibilities**Project...

  • Clinical Project Manager

    hace 2 semanas

    Barcelona, Barcelona, España Syneos Health, Inc. A tiempo completo

    About the Role**Job Summary**We are seeking an experienced Clinical Project Manager to join our team at Syneos Health, Inc. as a Sponsor Dedicated Clinical Project Manager. This is a home-based position in Spain, and we are looking for a professional with a strong background in clinical project management on global studies.Key Responsibilities**Project...

  • Medical Research Project Manager

    hace 2 semanas

    Barcelona, Barcelona, España Bayer (Schweiz) Ag A tiempo completo

    About the RoleBayer (Schweiz) Ag is seeking a highly skilled and experienced Medical Research Project Manager to join our team. As a Medical Research Project Manager, you will be responsible for managing and delivering medical research projects, ensuring that they are executed in accordance with Bayer's policies and procedures, as well as applicable...

  • Medical Research Project Manager

    hace 2 semanas

    Barcelona, Barcelona, España Bayer (Schweiz) Ag A tiempo completo

    About the RoleBayer (Schweiz) Ag is seeking a highly skilled and experienced Medical Research Project Manager to join our team. As a Medical Research Project Manager, you will be responsible for managing and delivering medical research projects, ensuring that they are executed in accordance with Bayer's policies and procedures, as well as applicable...

  • Clinical Operations Manager

    hace 4 días

    Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Operations Manager to join our team at Thermo Fisher Scientific. As a Clinical Operations Manager, you will be responsible for managing all clinical operational and quality aspects of allocated studies, ensuring compliance with ICH GCP and project-specific requirements.Key ResponsibilitiesDevelop and...

  • Clinical Operations Manager

    hace 4 días

    Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Operations Manager to join our team at Thermo Fisher Scientific. As a Clinical Operations Manager, you will be responsible for managing all clinical operational and quality aspects of allocated studies, ensuring compliance with ICH GCP and project-specific requirements.Key ResponsibilitiesDevelop and...

  • Clinical Project Manager

    hace 2 semanas

    Barcelona, Barcelona, España Syneos Health, Inc. A tiempo completo

    Job SummaryWe are seeking a highly skilled Clinical Project Manager to join our team at Syneos Health, Inc. as a Sponsor Dedicated Clinical Project Manager - Home Based in Spain.Key ResponsibilitiesProject Leadership and Delivery:• Manage projects as a project manager overseeing interdisciplinary clinical research studies and ensure compliance with Good...

  • Clinical Project Manager

    hace 2 semanas

    Barcelona, Barcelona, España Syneos Health, Inc. A tiempo completo

    Job SummaryWe are seeking a highly skilled Clinical Project Manager to join our team at Syneos Health, Inc. as a Sponsor Dedicated Clinical Project Manager - Home Based in Spain.Key ResponsibilitiesProject Leadership and Delivery:• Manage projects as a project manager overseeing interdisciplinary clinical research studies and ensure compliance with Good...

  • Clinical Project Manager II

    hace 5 días

    Barcelona, Barcelona, España Syneos Health, Inc. A tiempo completo

    Clinical Project Manager II RoleSyneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate clinical, medical affairs, and commercial insights into outcomes to address modern market realities.Our Clinical Development model puts the customer and patient at the center of everything we do. We continuously...

Study Manager

hace 3 meses

Barcelona, 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, nonconformances, 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 crossfunctional 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 closeout, and maintains internal and external inventory systems to reflect accurate inventory counts
  • Mentor, develop and generally supervise the activities of other members of coworkers (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 paperbased 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