Local Study Associate Director Cell Therapy

AstraZeneca

Barcelona, Spain
3 days onsite
Country study leadership
Site feasibility and selection
Ethics and regulatory submissions
AstraZeneca is seeking a Local Study Associate Director for Cell Therapy in Barcelona, responsible for leading local study teams, ensuring compliance with regulatory standards, and delivering clinical study commitments. The role requires strong leadership, expertise in clinical operations, and proficiency in both English and Spanish

Job Summary

  • Lead Local Study Team(s) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines.
  • Own delivery of country study commitments and data quality, leading CRAs and CSAs to meet milestones and uphold GCP and local regulations.
  • Your leadership at country level will connect directly to patients’ lives, turning complex protocols into reliable evidence that informs the next breakthrough.

Matching Summary

Match Score: 85

AstraZeneca is seeking a Local Study Associate Director for Cell Therapy in Barcelona, responsible for leading local study teams, ensuring compliance with regulatory standards, and delivering clinical study commitments. The role requires strong leadership, expertise in clinical operations, and proficiency in both English and Spanish.

Skills & Requirements

Must-have

  • Country study leadership
  • Site feasibility and selection
  • Ethics and regulatory submissions
  • Budget and contract management
  • Monitoring oversight and quality
  • Risk management and issue resolution
  • English and Spanish proficiency

Nice-to-have

  • Oncology clinical trial experience
  • Innovative trial designs
  • Global matrix influence
  • Process optimization success

Key Requirements

  • Proven leadership of local study execution
  • Expertise in clinical and operational feasibility
  • Experience managing ethics and regulatory submissions
  • Experience preparing and managing study budgets and contracts
  • Proficiency in preparing MICFs and site-level ICFs
  • Hands-on experience setting up and maintaining CTMS
  • Comprehensive monitoring oversight experience
  • Advanced risk management skills
  • Ability to lead effective Local Study Team meetings
  • Direct involvement in patient recruitment strategy
  • Competence in forecasting timelines, resources, recruitment
  • eTMF maintenance ensuring completeness
  • Coaching and performance feedback for CRAs/CSAs

Work Rights

Not specified

Tailored Resume

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