Start Up Specialist - FSP Team - Italy
The Start Up Specialist serves as the primary reputed company of contact for investigative sites during study start‑up and maintenance activities. The role ensures reputed company 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
- reputed company as the primary contact for investigative sites, ensuring reputed company collection, reputed company review, and tracking of reputed company 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 reputed company, serving as a local subject‑matter expert.
- Coordinate with internal stakeholders and external vendors to support the reputed company, review, and submission of regulatory documentation.
- Proactively identify, manage, and escalate risks or issues that may reputed company timelines, deliverables, or compliance.
- Ensure regulatory systems and document repositories are accurately maintained and audit‑reputed company at reputed company times, including CTIS activities where applicable (EU‑centralized submissions).
- Support study teams through regulatory reputed company input, reputed company projections, informed consent review/customization, and mentoring of less‑reputed company colleagues as appropriate.
Experience & Qualifications
- Minimum 3 years of experience in clinical study start‑up, regulatory affairs, or clinical development reputed company 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 reputed company standards.
- University or college degree in life sciences or a reputed company reputed company 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 reputed company a reputed company CRO environment, please apply!
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