Global Study Manager - Barcelona

Icon Clinical Plc

Barcelona

Presencial

EUR 110.000 - 140.000

Jornada completa

hace 34 horas
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Ventajas ofrecidas por este puesto de trabajo

annual leave entitlements
health insurance offerings
Employee Assistance Programme (EAP)
life assurance
flexible country-specific benefits

Descripción de la vacante

ICON Clinical Plc is seeking a Global Study Manager to lead global hematology studies in collaboration with AstraZeneca, ensuring timely delivery, budget discipline, and high quality. You will manage study setup, execution, and close-out within ICON’s FSP team, driving regulatory compliance and inspection readiness across regions.

The role emphasizes risk management, QA activities, and cross-functional partnerships, with a focus on early-phase hematology/oncology studies and AI automation in

Formación

  • Bachelor’s degree in life sciences or related field.
  • 5+ years in clinical research with 3+ years in global project management/GSM in Pharma or CRO.
  • Strong knowledge of ICH-GCP regulations.
  • Experience delivering studies on time and on budget.
  • Experience with internal and external vendor management and budgeting.

Responsabilidades

  • Plan, setup, and execute global clinical studies across regions.
  • Oversee country teams and third-party vendors for smooth delivery.
  • Collaborate with AstraZeneca internal teams and external partners.
  • Develop and update study documents (protocols, ICFs).
  • Manage contracts and budgets with vendors (e.g., central labs, IRT).
  • Ensure regulatory compliance (ICH-GCP, AstraZeneca SOPs) and quality standards.
  • Support risk management, QA activities, audits, and inspections.
  • Maintain inspection readiness and comprehensive study documentation.

Conocimientos

Communication
Teamwork
Problem solving
ICH-GCP knowledge
Budgeting
Vendor management
Clinical study lifecycle
Global project management
AI automation

Educación

Bachelor’s degree in life sciences

Descripción del empleo

As Global Study Manager, you enable global hematology studies in collaboration with AstraZeneca, ensuring timely delivery, budget discipline, and high quality. You work within ICON’s FSP team to integrate with client operations and external vendors, driving study setup, execution, and close-out. You’ll contribute to risk management, QA, and inspection readiness, shaping study documentation and regulatory compliance. This role offers impact through cross-functional partnerships and a focus on early-phase hematology/oncology studies.

  • annual leave entitlements
  • health insurance offerings
  • Employee Assistance Programme (EAP)
  • life assurance
  • flexible country-specific benefits
  • Plan, setup, and execute global clinical studies across regions
  • Oversee country teams and third-party vendors for smooth delivery
  • Collaborate with AstraZeneca internal teams and external partners
  • Develop and update study documents (protocols, ICFs)
  • Manage contracts and budgets with vendors (e.g., central labs, IRT)
  • Ensure regulatory compliance (ICH-GCP, AstraZeneca SOPs) and quality standards
  • Support risk management, QA activities, audits, and inspections
  • Maintain inspection readiness and comprehensive study documentation
  • Bachelor’s degree in life sciences or related field
  • 5+ years in clinical research with 3+ years in global project management/GSM in Pharma or CRO
  • Strong knowledge of ICH-GCP regulations
  • Proven track record delivering studies on time, on budget, to quality
  • Experience with internal and external vendor management and budgeting
  • Excellent communication, teamwork, and problem-solving skills
  • Ability to manage multiple priorities in a matrix environment
  • Experience across all phases of clinical study lifecycle
  • Experience in haematology or oncology early-phase studies
  • Experience using AI automation in daily work as a GSM
  • Knowledge of GXP beyond GCP (e.g., GMP, GLP)
  • teamwork
  • problem-solving
  • ICH-GCP knowledge
  • clinical study lifecycle
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