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.

Managing regulatory authority and ethics committee submissions across assigned projects, ensuring timely approvals for clinical trial initiation and conduction 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 Your new department 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 department.

Here,



a team of passionate professionals brings Novo Nordisk's global pipeline to Italian patients, running trials with excellence, agility and a shared commitment to quality. It is a place where curiosity is rewarded, collaboration is the norm, and every contribution has a direct impact on advancing therapies for people living with serious chronic diseases. Senior-level professional who serves as a role model, demonstrates deep clinical operations expertise, successfully manages complex studies, and proactively drives solutions, risk mitigation, and informed decision-making across functions.

A minimum of 3–5 years' experience in clinical trial study start-up, regulatory submissions or clinical operations within the pharmaceutical or biotech industry Solid knowledge of ICH-GCP guidelines, local regulatory requirements and the clinical trial approval process Experience with regulatory authority and ethics committee submission processes and timelines Proactive mindset towards digitalisation and the use of AI and other digital tools to drive efficiency and continuous improvement in daily work. A relevant university degree in life sciences, pharmacy, nursing or a related field (BSc or MSc) Proficiency in both Italian and English Every day we seek the solutions that defeat serious chronic diseases. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Incentives and Benefits The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks. September 25th, 2026 #

📌 Senior Study Start-Up Specialist (Roma, Lazio, IT)
🏢 Biopharma Careers
📍 Roma