14 set - Roma
Novo Nordisk Pharma
Every clinical trial begins with a critical first step – getting sites ready to enroll patients. In this role, you'll be the driving force behind regulatory and ethics submissions that open the door for breakthrough therapies to reach the people who need them. 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.
Competenze, Esperienza, Qualifiche: se possiede i requisiti giusti per questa occasione, si candidi oggi stesso.
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. Throug
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