Regulatory and Start-Up Specialist (Home-Based)

About the role

IQVIA is looking for an experienced RSU Specialist to join its FSP team in Poland. This is a home-based position requiring strong knowledge of local regulatory requirements, site activation processes and contract negotiations. Fluency in Polish is essential. You will be the main point of contact for investigative sites, Site Activation Managers, project teams and other stakeholders, making sure site activation is completed efficiently and in line with local regulations, SOPs and project timelines.

Key responsibilities

• Serve as the primary contact for investigative sites, Site Activation Managers, Project Managers and internal stakeholders.
• Coordinate and run country-specific site activation and regulatory activities.
• Prepare, review and distribute regulatory documentation to ensure completeness, accuracy and compliance.
• Track and manage submissions, approvals and execution of regulatory submissions, ethics committee submissions, informed consent forms, Investigator Pack release documentation and Clinical Trial Agreements.
• Support contract negotiation activities and timelines.
• Maintain accurate records in internal systems and tracking tools, monitor project milestones and flag risks with mitigation plans.
• Provide local regulatory expertise to project teams and Site Activation Managers, review site documentation and site performance metrics, and contribute to process improvement.
• Collaborate with sponsors and cross-functional teams to deliver successful study start-up and site activation.

Required profile

• Bachelor's degree in Life Sciences or a related scientific discipline.
• About 3.5 to 5 years of experience in clinical research.
• Fluency in Polish with strong English communication skills.

Required skills

• Strong experience in site activation, regulatory submissions, CTAs and contract negotiations, and clinical trial start-up.
• Solid understanding of Italian and international clinical trial regulations.
• Planning, organisation and problem-solving, ability to handle multiple priorities in a fast pace.
• Stakeholder management and communication.

What we offer

• Home-based flexibility within Poland.
• Work on innovative clinical studies across many therapeutic areas and sponsors.
• Career development and advancement opportunities.