Start-Up Associate II (Italy)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/89fyzc

Overview In this role you support local study start-up activities for clinical trials, acting as the primary liaison with regulatory bodies and ethics committees through site initiation. You manage regulatory documentation, eTMF/CTMS filing, and site contracts to ensure timely, compliant start-up. You collaborate with cross-functional teams to address questions from authorities and sites, keeping regulatory and ethical requirements up to date. This is a hands-on role at the start of a study that shapes site readiness and study execution.

Retribuzione / Benefits

Comprehensive benefits package per location Competitive salaries per location Training budget for professional development Flexible working hours Buddy program for newcomers Internal growth opportunities and career progression

Responsabilità

Coordinate local start-up activities and maintain trackers in CTMS or similar tools File and own documents in the (e)TMF and assist team members with filings Prepare, compile,



submit and maintain regulatory documentation for local trials Interact with regulatory authorities and respond to questions Prepare and compile ethical submissions to IEC/IRB and address inquiries Assist in adapting country SIS/ISF to site requirements and support contract processes Prepare, review and finalize CTAs, LOIs, budgets, and site-level agreements Obtain necessary signatures and ensure documentation complies with local regs Prepare Essential Document Package and liaise with Global Reviewer Track Investigational Product shipment authorization and status

Requisiti fondamentali

Life Science degree or equivalent >2 years of regulatory affairs experience in pharmaceutical/biotech Strong knowledge of local submission and reporting requirements Understanding of the drug development process Fluent Italian and English oral/written communication Attention to detail and teamwork excellent written and verbal communication attention to detail team player CTMS tracking (e)TMF document management regulatory submissions and interactions with authorities

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/89fyzc