Senior Study Start-Up Specialist (Roma, Lazio, IT)

Biopharma Careers; Roma; In loco; EUR 53.000 - 82.000; Tempo pieno

Vantaggi offerti da questo lavoro

Incentives

Benefits designed by market benchmarks

Descrizione del lavoro

Novo Nordisk Italy is seeking a Senior Study Start-up Specialist to enable clinical trials to launch on time and in compliance with local and international regulations. You will manage end-to-end study start-up, navigating regulatory landscapes to ensure sites are activated efficiently and patients access investigational treatments quickly.

You will oversee regulatory authority and ethics submissions, coordinate start-up documents through CTIS portal, ensure ICH-GCP compliance, and collaborate

Competenze

• Minimum 3–5 years' experience in clinical trial start-up or regulatory submissions.
• Solid knowledge of ICH-GCP guidelines and local regulatory requirements.
• Experience with regulatory authority submissions and timelines.
• Strong organizational skills with ability to manage multiple trials.
• Excellent communication and stakeholder management across cultures.
• Proficiency in Italian and English.
• Relevant university degree in life sciences, pharmacy or related field.

Mansioni

• 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 SOPs 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 with monitors, clinical trial administrators and legal team to negotiate and finalise site contracts and budgets
• Establish partnership with clinical trial managers to drive studies’ success and patient impact

Conoscenze

Clinical operations expertise

ICH-GCP knowledge

Regulatory submissions

Stakeholder management

Project management

Formazione

BSc or MSc life sciences

Descrizione del lavoro

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 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.

Your skills & qualifications

We're looking for a Senior Study Start-up Specialist who thrives in a fast-paced, global environment and takes ownership of delivering results. To succeed in this role, you'll bring:

• 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
• Strong organisational skills with the ability to manage multiple trials simultaneously while maintaining attention to detail
• Excellent communication and stakeholder management skills, with the ability to collaborate across cultures and functions
• 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

Applications from candidates based in other locations across Italy will also be considered.

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. 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.

Salary

For this role, the Annual Base Salary ranges from 53,180.00 to 82,430.00 EUR, corresponding to the level of the position.

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.

Deadline

September 25th, 2026