Senior Study Start-Up Specialist

Novo Nordisk A/S; Roma; In loco; EUR 53.000 - 82.000; Tempo pieno

Vantaggi offerti da questo lavoro

Salary disclosure at offer stage

Incentives and benefits package

Career development opportunities

Descrizione del lavoro

Novo Nordisk A/S in Italy is seeking a Senior Study Start-up Specialist to drive regulatory submissions and site activation for clinical trials, ensuring compliance with ICH-GCP and local requirements. You will manage end-to-end start-up, coordinate with internal and external stakeholders, maintain trial master file, and support contracts and budgets in a fast-paced, global environment.

Joining the Clinical Development Centre (CDC) in Trial Operations EUCAN, you will contribute to timely trial

Competenze

• Experience in regulatory submissions and ethics committee approvals.
• Strong knowledge of ICH-GCP and local regulations.
• Excellent stakeholder management across functions and cultures.
• Proficiency in both Italian and English.
• Experience with trial start-up processes in pharma/biotech.

Mansioni

• Managing regulatory authority and ethics committee submissions across assigned projects.
• Coordinating with stakeholders to collect, review and submit start-up documents through CTIS.
• Ensuring compliance with ICH-GCP and Novo Nordisk SOPs during trial conduct.
• Contributing to process improvements and sharing best practices in start-up teams.
• Maintaining trial master file documentation and start-up tracking systems.
• Collaborating with monitors, CTAs, legal teams to negotiate site contracts and budgets.
• Partnering with clinical trial managers to drive study success and patient impact.

Conoscenze

Regulatory submissions

Ethics committee submissions

Clinical operations

ICH-GCP knowledge

Stakeholder management

Italian language

English language

Digitalisation / AI tools

Startup experience

CTIS portal experience

Formazione

BSc or MSc in life sciences

Strumenti

CTIS portal

Descrizione del lavoro

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. 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 timelinesStrong 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.

For this role, the Annual Base Salary ranges from53,180.00 to 82,430.00 EUR, corresponding to the level of the position.

The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

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.

Learn more about our Reward Philosophy her e .