08 ott - Pistoia
Iqvia
Regulatory and Start Up Specialist - ItalyApply: Milan, Italy: Tempo pieno: Posted Today: R1572752### RSU SpecialistLevel: Senior Associate Location: Italy (Home Based) ### About IQVIAIQVIA 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 OpportunityWe 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 interna
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