[Hiring] Regulatory and Start Up Specialist @IQVIA

Role Description

We are seeking an experienced RSU Specialist to join our FSP team in Hungary. This home-based position requires strong knowledge of local regulatory requirements, site activation processes, and contract negotiations. Fluency in Hungarian 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.

Key Responsibilities

• 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.

Qualifications

• 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 Hungarian and international clinical trial regulations.
• Fluency in Hungarian 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.

Benefits

• Home-based flexibility within Hungary.
• Opportunity to work on innovative and impactful clinical studies.
• Exposure to a wide range of therapeutic areas and sponsors.
• Global career development and advancement opportunities.
• Collaborative and inclusive culture focused on growth and continuous learning.
• Join a team dedicated to accelerating healthcare innovation and improving patient outcomes worldwide.