Director Operations - Clinical Data Management

IPSEN

Paris, France
Hybrid
5-7 years cdm leadership experience
Quality management framework implementation
Regulatory compliance (ich, gcp, cdisc)
The Director Operations leads the development and oversight of administrative and trial operations to ensure Ipsen meets regulatory compliance and strategic goals

Job Summary

  • The Director Operations leads the development and oversight of administrative and trial operations to ensure Ipsen meets regulatory compliance and strategic goals.
  • This role is responsible for defining Quality Management frameworks, managing Standard Operating Procedures, and driving change management initiatives within the Clinical Data Management organization.
  • The position requires leading a team of pooled resources, managing external partners, and delivering inspection-ready databases on time and within budget.

Matching Summary

The Director Operations leads the development and oversight of administrative and trial operations to ensure Ipsen meets regulatory compliance and strategic goals.

Skills & Requirements

Must-have

  • 5-7 years CDM leadership experience
  • Quality Management framework implementation
  • Regulatory compliance (ICH, GCP, CDISC)
  • SOP management and training oversight
  • Change management methodology execution
  • KPI/KQI metrics tracking and reporting
  • Vendor and partner operational governance

Nice-to-have

  • Formal change management certification
  • Cross-cultural and geographic collaboration
  • Budget management understanding
  • Innovation initiative participation
  • French language proficiency

Key Requirements

  • 5-7 years in CDM leadership
  • Life Science or IT graduate degree
  • English language proficiency required
  • Proven project management skills
  • Experience with Service Provider relationships

Work Rights

Not specified

Tailored Resume

Cover Letter