Regulatory And Start Up Manager (com)

Ivivamedical

Amsterdam, Netherlands
Hybrid
Site activation and maintenance
Regulatory strategy and submissions
Clinical trial documentation
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs

Job Summary

  • Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs.
  • Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials.
  • Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.

Matching Summary

Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs.

Skills & Requirements

Must-have

  • site activation and maintenance
  • regulatory strategy and submissions
  • clinical trial documentation
  • GCP and ICH guidelines
  • Dutch language fluency

Nice-to-have

  • mentoring and coaching colleagues
  • relationship building with customers
  • presentation and training delivery

Key Requirements

  • Bachelor's Degree Life sciences or related field
  • 7 years’ relevant experience
  • International role experience
  • Regulated clinical trial environment understanding
  • Drug development process knowledge
  • Proficiency in systems and technology
  • Regulatory and/or technical writing skills
  • GCP and ICH guidelines knowledge
  • Leadership skills
  • Study financial management understanding

Work Rights

Not specified

Tailored Resume

Cover Letter