Clinical Operations Study Country Lead (coscl)

Sanofi

Tokyo, Japan
Clinical trial operations
Ich/gcp compliance
Local regulatory requirements
The COSCL will be a strategic leader within the Clinical Study Unit (CSU), accountable for the planning, execution, and oversight of clinical trials from country allocation through study closure and archiving

Job Summary

  • The COSCL will be a strategic leader within the Clinical Study Unit (CSU), accountable for the planning, execution, and oversight of clinical trials from country allocation through study closure and archiving.
  • This role ensures compliance with Sanofi SOPs, ICH/GCP, and local regulatory requirements, while leveraging AI-driven solutions to optimize processes.
  • The COSCL represents the country in global meetings, escalates risks, and owns country-level decisions to ensure successful study delivery.

Matching Summary

The COSCL will be a strategic leader within the Clinical Study Unit (CSU), accountable for the planning, execution, and oversight of clinical trials from country allocation through study closure and archiving.

Skills & Requirements

Must-have

  • clinical trial operations
  • ICH/GCP compliance
  • local regulatory requirements
  • AI-driven solutions
  • stakeholder collaboration
  • budget management

Nice-to-have

  • digital transformation leadership
  • innovative solutions implementation
  • ethical AI use
  • data privacy and governance

Key Requirements

  • Clinical study operation experience
  • Project management experience
  • Clinical trial oversight experience
  • GCP, ICH guidelines knowledge
  • Local regulatory requirements knowledge
  • Digital technologies implementation experience
  • AI-powered tools and data analytics experience
  • Business-level English proficiency

Work Rights

Not specified

Tailored Resume

Cover Letter