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Global Study Associate Director

astrazeneca · Barcelona

New
Senior 🇬🇧 English
ICH-GCP Clinical Study Management Clinical Study Protocol Clinical Study Report Trial Master File ACCORD/ABACUS PharmaCM

Job description

About the role

AstraZeneca is looking for a Global Study Associate Director based in Barcelona, with an on-site commitment of three days a week and fluency in English required. The role leads a cross-functional study team from handover through close-out and archiving, acting as the link between the study team and the Clinical Program Team. It owns study delivery against timelines, budgets and quality standards, ensures inspection readiness and oversees multi-country operations.

Key responsibilities

  • Lead, guide and delegate to a cross-functional study team or oversee outsourced delivery, driving milestones on time, within budget and to quality standards; may oversee several studies.
  • Facilitate communication across functions and external partners, and lead investigator meetings and other study meetings.
  • Contribute to and own essential study documents (Clinical Study Protocol to Clinical Study Report) in line with AZ SOPs.
  • Monitor external service providers (CROs, central laboratories, IXRS, ePRO) against contracted goals and timelines, document oversight and escalate issues; may take part in vendor selection.
  • Develop study plans, including quality and risk management planning, with clear risk responses and escalation pathways.
  • Keep study systems (e.g. ACCORD/ABACUS, PharmaCM) current and accurate, and track performance against KPIs.
  • Report quality issues and CAPAs, and ensure the Trial Master File is complete with ongoing QC.
  • Manage study budget re-forecasting and reporting, and ensure studies remain inspection-ready under ICH-GCP and AZ SOPs.
  • Give regular performance feedback, mentor less experienced colleagues, and take on non-drug project work or act as a subject matter expert.

Required profile

  • University degree, preferably in medical or biological sciences or a clinical research discipline.
  • 5 years of relevant clinical experience in the pharmaceutical industry, including 2 years of project management, or an equivalent combination of education, training and experience.
  • Desirable: advanced degree, project management certification, global project management experience, and experience across all phases of a clinical study lifecycle.

Required skills

  • Extensive knowledge of ICH-GCP and clinical research regulatory requirements.
  • Solid project management skills and knowledge of relevant tools.
  • Strong team leadership, communication, stakeholder relationship and conflict management skills.
  • Strategic thinking, organisation, problem solving and ability to manage competing priorities.

Questions fréquentes

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Source : ats:workday

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Published 13 minutes ago

Expires 1 month from now

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astrazeneca

Barcelona