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
- 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
- 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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