Start Up Specialist FSP Team Italy

The Start Up Specialist serves as the primary point of contact for investigative sites during study startup and maintenance activities. The role ensures timely and compliant submission of documentation to EC/IRB/Regulatory Authorities adherence to applicable regulations and ICHGCP 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 startup 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 uptodate knowledge of regulatory legislation guidance and best practices in assigned countries or regions serving as a local subjectmatter 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 auditready at all times including CTIS activities where applicable (EUcentralized submissions).
• Support study teams through regulatory strategy input timeline projections informed consent review/customization and mentoring of lessexperienced colleagues as appropriate.

Experience & Qualifications

• Minimum 3 years of experience in clinical study startup regulatory affairs or clinical development within a CRO or pharmaceutical environment.
• Strong working knowledge of ICHGCP EC/IRB/IEC processes Regulatory Authority requirements and investigator startup 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 crossfunctional project teams.

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

Learn more about our EEO & Accommodations request here.