Regulatory and Start Up Specialist - Italy

RSU Specialist

Level: Senior Associate
Location: Italy (Home Based)

About IQVIA

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.

The Opportunity

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

What We're Looking For

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

Why Join IQVIA?

• Home-based flexibility within Italy.
• 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.

At IQVIA, we believe diversity, inclusion, and belonging are key to driving innovation. We are committed to creating an environment where every individual can bring their authentic self to work and contribute to improving healthcare for patients around the world.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is €41 000,00 - €61 400,00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.