Regulatory And Start Up Manager (com)

IQVIA

Amsterdam, Netherlands
Hybrid
Site activation and regulatory activities
Clinical trial management plan
Regulatory intelligence analysis
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.
  • Oversee the execution of Site Activation and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
  • Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.

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 Regulatory Activities
  • Clinical Trial Management Plan
  • Regulatory Intelligence Analysis
  • GCP and ICH Guidelines
  • Dutch Language Fluency

Nice-to-have

  • Relationship building with customers
  • Mentoring and coaching colleagues
  • Client and professional presentations

Key Requirements

  • Bachelor's Degree Life sciences or related field
  • 7 years relevant experience
  • International role experience
  • Regulated clinical trial environment understanding
  • Clinical Practice (GCP) and ICH guidelines knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter