Global Study Manager

hace 6 días

Barcelona, España AstraZeneca GmbH A tiempo completo

Are you ready to make a difference in the world of clinical research? As a Global Study Manager (GSM) within Development Operations, you will be an integral part of the global study team, supporting the delivery of clinical studies from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, and development of Clinical Study Report (CSR) to study archiving. You will collaborate with internal and external partners to ensure the successful execution of delegated aspects of clinical studies across various therapeutic areas and phases (I-IV, including Late Phase, Non-Interventional, Post Authorization Safety Studies, Registries, Early Access Programs, etc.). Your role will involve driving scope of work discussions, overseeing day-to-day activities delegated to vendors, providing status updates, and developing, reviewing, and approving related study documents.

Accountabilities

  1. The strategy, set up and oversight of key vendors in support of study deliverables according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the vendors is maintained and documented through the life cycle of the study.
  2. Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives.
  3. Contributes to the planning and conduct of internal and external meetings (e.g., Investigators’/Monitors’ meeting).
  4. Supports the Study Lead with budget management, such as external service provider invoice reconciliation.
  5. Supports the Study Lead (GSAD, GSD) with developing and maintaining relevant study documents/plans (e.g., global study management plan and its relevant components, etc.).
  6. Perform Study Lead activities for less-complex studies (e.g., small studies, studies in conduct or close-out, OLE, etc.).
  7. Delegate and oversee team member responsibilities.
  8. Conduct lessons learned exercise to help document continuous improvement process and sharing of best practices.
  9. Participate in and/or lead departmental initiatives and/or SME function.
  10. Coordination and reporting of start-up and recruitment activities at the study level, across all countries.
  11. Monitoring and site oversight globally on assigned study(ies), representing the monitoring function on the CTT.
  12. Aggregation and communication of deliverables for assigned study(ies), globally, to the CTT and country teams respectively.
  13. Resourcing (with assistance of country teams) and study-related training of CRAs for assigned study(ies).
  14. Developing and/or reviewing applicable study documents including, but not limited to, training materials, clinical monitoring and oversight plans.
  15. Coordinating country teams activities related to key study events, such as protocol amendments, interim database locks, and Investigator Meetings.
  16. Post final database lock, overseeing country activities related to site close out activities and post-trial access, as required.
  17. Support other study and functional activities, as assigned.

Essential Skills/Experience

  • >5 years of clinical research experience, 3 of which in a leading role accountable for the planning and execution of global clinical trials.
  • Bachelor’s degree or equivalent, in one of the disciplines related to clinical practice/health care, life sciences, or drug development, or commensurate work experience.
  • Excellent organizational communication and time management skills.
  • Highly proactive and willing to take initiative.
  • Strong relationship building skills.

The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Desirable Skills/Experience

  • PMP certification desirable.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are driven by our passion for science and our commitment to patients. Our work in rare disease biopharma is at the forefront of biomedical science, pushing boundaries to translate complex biology into transformative medicines. With our resources and global reach, we are uniquely positioned to shape the future of rare disease treatment and help people live their best lives. Our culture fosters innovation, inclusiveness, and a deep connection to our patients' journeys.

Ready to join us on this exciting journey? Apply now

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.

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