ph3Job Overview: /h3 pAt /p h3Job Description /h3 h3Job Overview: /h3 pAt bFortrea /b, we are committed to accelerating clinical trials and ensuring regulatory compliance.
As a bSite Start-Up Specialist /b, you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently.
Your expertise will help bring life-changing treatments to patients faster.
In this role, you will be part of our FSPx team and work directly with one of our renowned key sponsor to advance the development of innovative, life-changing medications.
/p h3Key Responsibilities /h3 pIn this role, you will: /p ul liServe as the primary contact for investigative sites during start-up and maintenance activities.
/li liCollect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).
/li liEnsure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.
/li liPrepare and submit regulatory documents, including country-specific application forms and informed consent forms.
/li liTrack submission timelines and proactively address potential delays.
/li liCollaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.
/li liEnsure all documentation is audit-ready and systems are consistently updated.
/li liAssist in the negotiation of site contracts and budgets, if applicable.
/li liProvide mentorship and training to new hires and less-experienced colleagues.
/li /ul h3Required Qualifications /h3 pTo succeed in this role, you should have:



/p ul liUniversity/College degree (life sciences preferred) or certification in a related allied health profession.
/li liMinimum 2 years of experience in clinical research, regulatory submissions, or site activation.
/li liStrong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.
/li liAbility to review and adapt patient informed consent forms to meet local and protocol-specific requirements.
/li liExperience interacting with regulatory authorities and site start-up teams.
/li liExcellent organizational, problem-solving, and communication skills.
/li liProficiency in Microsoft Office and document management systems.
/li liFortrea may consider relevant and equivalent experience in lieu of educational requirements.
/li /ul h3What We Offer /h3 ul liCompetitive salary and performance-based incentives.
/li liProfessional growth opportunities in a collaborative and innovative environment.
/li liThe opportunity to work on cutting-edge clinical research projects.
/li /ul pThe base salary range for this role is EUR 32,200 – EUR 46,000 gross per year, which may vary as per working schedule (full or part-time).
The final offer will be determined based on objective and job-related criteria such as experience, qualifications, and scope of responsibilities, in line with our internal job classification framework and the applicable collective labour agreement (CCNL).
This role may also be eligible for additional compensation, such as premio and benefits, in accordance with company policies.
/p pLearn more about our EEO Accommodations request here.
/p /p #J-*****-Ljbffr

📌 Start-Up Specialist- Fsp Model - Italy (Milano)
🏢 Fortrea
📍 Milano