Global Study Manager - Late Development Oncology

AstraZeneca

Barcelona

Presencial

EUR 80.000 - 120.000

Jornada completa

Hace 4 días
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Descripción de la vacante

AstraZeneca in Spain seeks a results-driven Study Lead to orchestrate complex, global oncology trials. You’ll connect science with disciplined execution, ensuring studies move from protocol to publishable results with speed, quality, and care.

You will partner with internal teams and external collaborators to deliver on time and within budget, maintaining inspection readiness and global alignment across multiple countries.

Formación

  • University degree (or equivalent) in medical or biological sciences or related discipline.
  • At least 3 years’ experience in pharmaceutical or clinical research environments.
  • Knowledge of clinical development processes and therapy areas.

Responsabilidades

  • Study Delivery Leadership: oversee delegated aspects of study execution to meet time, cost and quality goals.
  • Cross-Functional Orchestration: coordinate internal functions and CROs for multi-country delivery.
  • Documentation ownership for delegated study documents and external provider materials.
  • Plan and facilitate meetings with Investigators and Monitors to align stakeholders.
  • Ensure supply readiness of investigational product with Clinical Supply Chain partners.
  • Identify risks and issues, develop mitigation plans, and drive resolution.
  • Maintain Trial Master File readiness compliant with ICH/GCP standards.
  • Budget and vendor oversight, including CRO management and invoicing reconciliation.
  • Provide project management support to Global Study Directors/Associate Directors.
  • Coordinate across countries to balance local requirements with global standards.

Conocimientos

Communication skills
Project management
Collaboration
English proficiency

Educación

University degree in medical/biological sciences

Herramientas

TMF/eTMF systems
External vendor management

Descripción del empleo

Are you ready to orchestrate complex, global oncology studies that accelerate lifesaving medicines to patients? In this role, you will connect scientific ambition with disciplined execution, ensuring pivotal trials move from protocol to meaningful results with speed, rigor and care. You will partner across internal functions and world-class external collaborators to deliver studies to time, cost and quality. Working at the heart of global programs, you will turn plans into action, resolve challenges before they **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 providers, including contract specifications, KPIs and quality standards.
  • Strong familiarity with TMF/eTMF systems and inspection readiness for regulatory audits.
  • Hands-on experience with clinical supply planning, EDC and data management interfaces.
  • Budget tracking, invoice reconciliation and financial governance in a study context.
  • Fluency in additional languages to support global stakeholder engagement.

Why AstraZeneca: Here, diverse minds come together to push the boundaries of what's possible in cancer care, bringing academia and industry into the same room to unleash bold thinking. You will work with collaborative teams powered by curiosity and courage, with inclusive leadership and broad external partnerships that accelerate research in some of the hardest-to-treat cancers. We blend world-class science with practical execution, value kindness alongside ambition, and give you the platform to grow while making a direct impact on patients.

Date Posted

24-sept-2026

Closing Date

07-oct-2026

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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