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Global Study Manager - Late Development Oncology
Trabajo disponible en:
08001, Barcelona, Cataluna, España
Publicado en 2026-09-26
Empresa:
AstraZeneca
Tiempo completo
puesto Publicado en 2026-09-26
Especializaciones laborales:
-
Servicios Médicos
Investigación clínica
Descripción del trabajo
** escalate**, and keep teams aligned on outcomes that matter.
Can you see yourself driving inspection-ready performance while enabling innovative approaches to study delivery?
Accountabilities:
Study Delivery Leadership:
Provide oversight of delegated aspects of study execution to meet time, cost and quality goals from protocol development through close-out and archiving.
Cross-Functional Orchestration:
Maintain and facilitate interactions with internal functions and external providers (including CROs) to drive efficient, consistent delivery across countries.
Document Ownership:
Lead/contribute to the preparation of delegated study documents (e.g., Informed Consent Form, master Clinical Study Agreement) and external provider materials (specifications, procedures, presentations) to ensure clarity and compliance.
Meeting Planning and Facilitation:
Contribute to the planning and conduct of internal and external meetings, including Investigators' and Monitors' meetings, to align stakeholders and accelerate readiness.
Supply Readiness:
Ensure timely supply of investigational product and study materials by liaising with Clinical Supply Chain and external partners.
Risk and Issue Management:
Proactively identify risks and issues, develop mitigation and action plans, and drive resolution to maintain study momentum.
Inspection Readiness and Quality:
Ensure all study documents within scope are complete and verified in the Trial Master File; adhere to global clinical processes, SOPs and ICH/GCP so the study is inspection ready at all times.
Budget and Vendor Oversight:
Support budget management, including external provider invoice reconciliation; for outsourced studies, support oversight of the CRO Project Manager to deliver to agreed timelines, budget and quality standards, with documented oversight.
Project Management Support:
Support Global Study Directors/Associate Directors in project management per agreed delegation, applying established frameworks and best practices.
Global Coordination:
Operate across multiple countries, balancing local requirements with global standards to enable consistent execution and impact at scale.
Essential Skills/
Experience:
University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
Knowledge of clinical development / drug development process in various phases of development and therapy areas
Excellent knowledge of international guidelines ICH/GCP
Excellent communication and relationship building skills, including external service provider management skills Good project management skills.
Demonstrated ability to collaborate as well as work independently Demonstrated leadership skills.
Computer proficiency, advanced computer skills in day-to-day tasks Excellent verbal and written communication in English
Desirable Skills/
Experience:
Advanced degree in a relevant field and/or formal project management certification (e.g., PMP, PRINCE2).
Experience delivering global, multicountry oncology studies in late-stage development.
Proven oversight of CROs and external service…
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