Regulatory and Start Up Specialist - Netherlands

Level: Senior Associate
Location: Netherlands (Home Based)

IQVIA is a leading global provider of clinical research services, healthcare intelligence, and commercial insights to the life sciences industry. With more than 88,000 employees worldwide, we help accelerate the development and commercialization of innovative treatments that improve patient outcomes and population health.

As a global leader in clinical development, we combine data, technology, scientific expertise, and operational excellence to help our customers navigate the complex healthcare landscape and bring new therapies to patients faster.

We are seeking an experienced RSU Specialist to join our Site Activation team in Netherlands. This home-based position requires strong knowledge of local regulatory requirements, site activation processes, and contract negotiations. Fluency in Dutch is essential.

In this role, you will act as the key point of contact for investigative sites, Site Activation Managers (SAMs), project teams, and other stakeholders, ensuring site activation activities are completed efficiently and in compliance with local regulations, SOPs, and project timelines.

• →Serve as the primary point of contact for investigative sites, Site Activation Managers, Project Managers, and internal stakeholders.
• →Coordinate and execute country-specific site activation and regulatory activities.
• →Prepare, review, and distribute regulatory documentation to ensure completeness, accuracy, and compliance.
• →Track and manage submission, approval, and execution of essential documents, including:
  • →Regulatory submissions
  • →Ethics Committee submissions
  • →Informed Consent Forms (ICFs)
  • →Investigator Pack (IP) release documentation
  • →Clinical Trial Agreements (CTAs)
• →Support contract negotiation activities and timelines.
• →Maintain accurate records within internal systems and tracking tools.
• →Monitor project milestones and proactively identify risks and mitigation plans.
• →Provide local regulatory expertise to project teams and Site Activation Managers.
• →Perform quality reviews of site documentation.
• →Review site performance metrics and contribute to continuous process improvement initiatives.
• →Collaborate closely with sponsors and cross-functional teams to ensure successful study start-up and site activation delivery.

• Bachelor's Degree in Life Sciences or a related scientific discipline.
• Approximately 3.5 to 5 years' experience within clinical research.
• Strong experience in:
  • Site Activation
  • Regulatory submissions
  • Clinical Trial Agreements (CTAs) and contract negotiations
  • Clinical trial start-up activities
• Solid understanding of Belgian and international clinical trial regulations.
• Fluency in Dutch with strong English communication skills.
• Excellent planning, organization, and problem-solving abilities.
• Ability to manage multiple priorities and work effectively in a fast-paced environment.
• Strong stakeholder management and communication skills.