Global Study Manager, Oncology R&d, Early Oncology Clinical

AstraZeneca

Study document development and compliance
Country-specific clinical trial start-up leadership
Third-party vendor management and budgeting
As a Global Study Manager, you will turn complex protocols into operational reality, enabling decisive progress in first-in-human and proof-of-concept trials that put patients first

Job Summary

  • As a Global Study Manager, you will turn complex protocols into operational reality, enabling decisive progress in first-in-human and proof-of-concept trials that put patients first.
  • Your work will ensure study start-up, recruitment, data delivery and inspection readiness happen without delays while managing timelines, budget control and regulatory success across a global network of sites.
  • AstraZeneca fosters a community united by a clear purpose to transform outcomes for people living with cancer, offering stretch opportunities, trusted ownership and collaborative problem-solving.

Matching Summary

As a Global Study Manager, you will turn complex protocols into operational reality, enabling decisive progress in first-in-human and proof-of-concept trials that put patients first.

Skills & Requirements

Must-have

  • Study document development and compliance
  • Country-specific clinical trial start-up leadership
  • Third-party vendor management and budgeting
  • Data management collaboration and delivery
  • Clinical trial financial stewardship
  • Investigational product and materials coordination
  • Trial Master File management and inspection readiness

Nice-to-have

  • Experience with early-phase oncology trials
  • Familiarity with ICH-GCP and global regulations
  • Proficiency with clinical systems like EDC and CTMS
  • Strong budget management and contract negotiation
  • Cross-functional team leadership skills
  • Analytical skills for operational risk mitigation
  • Clear and concise stakeholder communication

Key Requirements

  • Proven experience in study document development and amendments
  • Experience leading country-specific clinical trial applications
  • Demonstrated vendor setup and management expertise
  • Experience with data management documents and site collaboration
  • Capability to manage contracts, budgets, and invoices
  • Experience coordinating investigational product supply
  • Experience supporting clinical trial insurance processes
  • Experience monitoring study conduct and resolving issues
  • Experience supporting risk management and quality compliance
  • Experience managing Trial Master File with inspection readiness
  • Experience supporting audits and regulatory inspections
  • Experience reviewing SOPs and guidance documents

Work Rights

Not specified

Tailored Resume

Cover Letter