Global Study Manager

Responsibilities

• Lead delegated aspects of global haematology clinical studies from protocol to publication
• Manage third-party vendors and CROs, including oversight of statements of work, budgets, and change orders
• Contribute to the development of study documents, including Informed Consent Forms and country-specific materials
• Partner with cross-functional teams across Data Management, Regulatory, Patient Safety, and Quality Assurance
• Oversee study start-up, maintenance, and close-out activities, including investigator and monitor meetings
• Ensure study inspection readiness by maintaining compliance with ICH-GCP, SOPs, and quality guidelines
• Support budget management and external service provider invoice reconciliation

Requirements

• Bachelor's degree in medical or biological sciences or a related clinical research discipline
• Minimum of 5 years of progressive experience in clinical research
• At least 3 years of clinical development project management experience
• Minimum of 1 year of experience specifically as a Global Study Manager
• Extensive knowledge of clinical research regulatory requirements, including ICH-GCP
• Proven experience in matrix team leadership and managing internal and external stakeholders

Preferred Qualifications

• Higher university degree such as a PhD or MSc
• Experience across all phases of the clinical study lifecycle
• Experience within the Haematology or Oncology therapeutic areas
• Basic knowledge of GXP outside of GCP (e.g., GMP/GLP)
• Experience in vendor management for specialized services like IRT or laboratories

Benefits

• Award-winning company culture with high employee recommendation rates
• Inclusive environment with a focus on diversity and equality
• Support for work-life balance, including annual leave and reduced-hours timetables
• Comprehensive benefits including retirement plans and health insurance

About the Company

AstraZeneca is a leading global biopharmaceutical company dedicated to delivering life-changing medicines. We combine science and technology to tackle some of the world's most complex diseases, working as one collaborative team to serve patients every day.