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

Trzdev7

Study document development and compliance
Country start-up leadership
Vendor set-up and management
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.
  • When urgent opportunities arise, we mobilize quickly—turning ideas into well-designed trials and actionable data in weeks, not months.

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 Start-up Leadership
  • Vendor Set-up and Management
  • Data Delivery Enablement
  • Financial Stewardship
  • Investigational Product and Materials Supply
  • Operational Oversight Across the Lifecycle
  • Recruitment and Risk Mitigation
  • Insurance Management
  • Study Monitoring and Issue Resolution
  • Risk Management and Quality
  • TMF Excellence
  • Communication and Engagement
  • Audit and Inspection Readiness
  • Continuous Improvement

Nice-to-have

  • Early-phase oncology trials
  • Global regulatory requirements
  • ICH-GCP familiarity
  • Cross-functional team leadership
  • Anticipate operational risks
  • Executive-ready materials

Key Requirements

  • Proven experience contributing to study document development
  • Experience leading country-specific agreements
  • Demonstrated ability to set up and manage third-party vendors
  • Experience providing input to data management documents
  • Capability to initiate contract and budget requests
  • Experience coordinating investigational product and study materials supply
  • Experience overseeing third-party vendors and investigator sites
  • Experience supporting recruitment and implementing risk mitigation
  • Experience assisting with clinical trial insurance processes
  • Experience monitoring study conduct and resolving issues
  • Experience supporting risk management and quality efforts
  • Experience setting up, maintaining, closing and archiving the Trial Master File
  • Experience preparing presentation materials
  • Experience supporting audits and regulatory inspections
  • Experience contributing to review of SOPs and guidance documents

Work Rights

Not specified

Tailored Resume

Cover Letter