18 set - Italia
Altro
Every clinical trial begins with a critical first step – getting sites ready to enroll patients.
Your new role As a Senior Study Start-up Specialist, you will play a pivotal role in enabling clinical trials to launch on time and in compliance with local and international regulations. You will manage the end-to-end study start-up process, navigating complex regulatory landscapes to ensure sites are activated efficiently and patients can access investigational treatments as quickly as possible.
Your key responsibilities will include: Managing regulatory authority and ethics committee submissions across assigned projects, ensuring timely approvals for clinical trial initiation and conduction
Coordinating with internal and external stakeholders to collect, review and submit essential start-up documents through CTIS portal
Ensuring compliance with ICH-GCP guidelines, local regulations and Novo Nordisk standard operating procedures throughout trial conduction
Contributing to process improvements and sharing best practices across local and global study start-up team
Maintaining accurate and up-to-date trial master file documentation and start-up tracking systems
Collaborating closely with other affiliate's functions including monitors and clinical trial administrator for start-up activities and legal team to negotiate and finalise site contracts and budgets
Establish partnership with clinical trial managers to drive studies' success and patient impact
Your new department In Global Trial Portfolio (GTP), you'll be part of a department that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs.
You will join the Clinical Development Centre (CDC), the dedicated hub for clinical operations in Italy and an integral part of Trial Operations EUCAN in GTP depa
18 set - Chiavari
Acrobatica
18 set - Fonzaso
Greta
18 set - Trento
Car Clinic
18 set - Nola
Demetra Formazione