Start-up specialist-FSP

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7kpltv

ppAt Fortrea, we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist, 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. /ph3Key Responsibilities /h3ulliServe as the primary contact for investigative sites during start-up and maintenance activities. /liliCollect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority). /liliEnsure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications. /liliPrepare and submit regulatory documents, including country-specific application forms and informed consent forms. /liliTrack submission timelines and proactively address potential delays. /liliCollaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities. /liliEnsure all documentation is audit-ready and systems are consistently updated. /liliAssist in the negotiation of site contracts and budgets, if applicable. /liliProvide mentorship and training to new hires and less-experienced colleagues. /li /ulh3Required Qualifications /h3ulliUniversity/College degree (life sciences preferred) or certification in a related allied health profession. /liliMinimum 2 years of experience in clinical research, regulatory submissions, or site activation. /liliStrong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.



/liliAbility to review and adapt patient informed consent forms to meet local and protocol-specific requirements. /liliExperience interacting with regulatory authorities and site start-up teams. /liliExcellent organizational, problem-solving, and communication skills. /liliProficiency in Microsoft Office and document management systems. /li /ulh3What We Offer /h3ulliCompetitive salary and performance-based incentives. /liliProfessional growth opportunities in a collaborative and innovative environment. /liliThe opportunity to work on cutting-edge clinical research projects. /li /ulpThe 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). /ppThe 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). /ppThis role may also be eligible for additional compensation, such as premio and benefits, in accordance with company policies. /ppLearn more about our EEO Accommodations request here. /ppDidn't find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. /ppFollow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. /ppAt Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job - it's a journey of making the exceptional possible, every day. /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7kpltv