Regulatory and Start Up Specialist
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As an RSU Specialist, you will lead country-specific site activation and regulatory activities within IQVIA's FSP team in Italy. You will act as the primary liaison for investigative sites and project teams, ensuring compliant, timely site activation and regulatory documentation. You will leverage local regulatory expertise to support timelines, risk mitigation, and cross-functional collaboration. This role offers the chance to influence start-up processes across diverse therapeutic areas in a global, growth-oriented environment.
Retribuzione / Benefits 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
Commitment to integrity in hiring and candidate honesty
Responsabilità Serve as the main point of contact for investigative sites, SAMs, Project Managers, and internal stakeholders
Coordinate and execute country-specific site activation and regulatory activities
Prepare, review, and distribute regulatory documentation for completeness and compliance
Track submission, approval, and execution of essential documents (regulatory submissions, ethics committee submissions, ICFs, IP release, CTAs)
Support contract negotiations and timelines
Maintain accurate records in internal systems and tracking tools
Monitor milestones and proactively identify risks with 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
Collaborate with sponsors and cross-functional teams to ensure successful study start-up and site activation delivery
Requisiti fondamentali Bachelor's Degree in Life Sciences or related discipline
Approximately 3.5 to 5 years' experience in clinical research
Strong experience in site activation, regulatory submissions, CTAs and contract negotiations, and start-up activities
Solid understanding of Italian and international clinical trial regulations
Fluency in Italian and strong English communication skills
Excellent planning, organization, and problem-solving abilities
Ability to manage multiple priorities in a fast-paced environment
Strong stakeholder management and communication skills
planning and organization
problem-solving
stakeholder management
regulatory submissions
Ethics Committee submissions
Informed Consent Forms
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