Start Up Specialist - FSP Team - Italy

The Start Up Specialist serves as the primary point of contact for investigative sites during study start‑up and maintenance activities. The role ensures timely and compliant submission of documentation to EC/IRB/Regulatory Authorities, adherence to applicable regulations and ICH‑GCP standards, and effective collaboration with internal study teams to support site activation and ongoing regulatory maintenance.

Key Responsibilities

• Act as the primary contact for investigative sites, ensuring timely collection, quality review, and tracking of all essential start‑up and regulatory documents.
• Prepare, compile, and submit regulatory and ethics applications (e.g., EC/IRB/IEC/Regulatory Authority submissions) in accordance with local regulations, sponsor requirements, and agreed project timelines.
• Maintain up‑to‑date knowledge of regulatory legislation, guidance, and best practices in assigned countries or regions, serving as a local subject‑matter expert.
• Coordinate with internal stakeholders and external vendors to support the generation, review, and submission of regulatory documentation.
• Proactively identify, manage, and escalate risks or issues that may impact timelines, deliverables, or compliance.
• Ensure regulatory systems and document repositories are accurately maintained and audit‑ready at all times, including CTIS activities where applicable (EU‑centralized submissions).
• Support study teams through regulatory strategy input, timeline projections, informed consent review/customization, and mentoring of less‑experienced colleagues as appropriate.

Experience & Qualifications

• Minimum 3 years of experience in clinical study start‑up, regulatory affairs, or clinical development within a CRO or pharmaceutical environment.
• Strong working knowledge of ICH‑GCP, EC/IRB/IEC processes, Regulatory Authority requirements, and investigator start‑up documentation.
• Demonstrated ability to manage multiple submissions and studies simultaneously while meeting timelines and quality standards.
• University or college degree in life sciences or a related healthcare discipline preferred; equivalent experience will be considered.
• Excellent communication and stakeholder management skills, with prior interaction with investigative sites and cross‑functional project teams.

If you are interested in supporting global clinical trials through regulatory expertise and site start‑up execution within a collaborative CRO environment, please apply!

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