Study Start-up Manager

ICON Clinical Research, LP

Utrecht, Netherlands
Study start-up management
Clinical trial protocol compliance
Ich/gcp guidelines adherence
This role is responsible for ensuring the performance and compliance of assigned clinical trial protocols within a country, in alignment with ICH/GCP guidelines, local regulations, company policies and procedures, quality standards, and adverse event reporting requirements

Job Summary

  • This role is responsible for ensuring the performance and compliance of assigned clinical trial protocols within a country, in alignment with ICH/GCP guidelines, local regulations, company policies and procedures, quality standards, and adverse event reporting requirements.
  • Responsibilities include, but are not limited to: Budget & Contracts: Own country and site budgets, including the development, negotiation, and execution of Clinical Trial Research Agreements (CTRAs).
  • ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work life balance opportunities for you and your family.

Matching Summary

This role is responsible for ensuring the performance and compliance of assigned clinical trial protocols within a country, in alignment with ICH/GCP guidelines, local regulations, company policies and procedures, quality standards, and adverse event reporting requirements.

Skills & Requirements

Must-have

  • Study start-up management
  • Clinical trial protocol compliance
  • ICH/GCP guidelines adherence
  • Country-level budget management
  • Regulatory submissions and approvals
  • Site readiness oversight

Nice-to-have

  • Fostering inclusive environment
  • Driving innovation and excellence
  • Mentoring colleagues and sharing best practices
  • Process optimization and best practices

Key Requirements

  • Bachelor's degree in life sciences
  • Extensive study start-up experience
  • Proven leadership skills
  • Excellent organizational and project management skills
  • Strong communication and stakeholder management skills

Work Rights

Not specified

Tailored Resume

Cover Letter