14 sep
|
Icon Clinical
|
Barcelona
14 sep
Icon Clinical
Barcelona
Overview
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.
Compensaciones / Incentivos
- annual leave entitlements
- health insurance offerings
- retirement planning
- Employee Assistance Programme (EAP)
- life assurance
- flexible country-specific benefits
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
Requisitos principales
- 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)
- excellent communication
- teamwork
- problem-solving
- vendor management
- ICH-GCP knowledge
- clinical study lifecycle
📌 Global Study Manager - barcelona
🏢 Icon Clinical
📍 Barcelona