Clinical Research Associate 2

Clinical Research Associate 2

Category: Clinical Development

Location: Roma, Lazio, IT

Are you passionate about clinical research and driven by the opportunity to bring life-changing therapies closer to patients? Join Novo Nordisk in Italy as a Clinical Research Associate II and play a pivotal role in shaping the future of clinical trials in obesity, diabetes and other serious chronic diseases. Apply today for a career where your expertise makes a tangible difference.

Your new role

As a Clinical Research Associate II, you will provide strategic oversight and management of clinical trial sites, ensuring protocol compliance, data integrity, and the protection of patient safety and rights. You will drive study quality and performance through risk-based monitoring and proactive risk management, collaborating with site staff and cross-functional teams to ensure the successful execution of our trials.

Your key responsibilities will include:

Act as a Site Manager, building trusted partnerships with investigators and site staff, driving site engagement and performance, and ensuring high-quality trial execution throughout the study lifecycle.

Conducting on-site and remote visits (site selection, initiation, monitoring and close-out) in accordance with the Monitoring Plan, Protocol, ICH-GCP, internal SOPs and regulatory requirements

Driving the implementation of Risk-Based Quality Management (RBQM) principles to proactively identify, assess and mitigate risks throughout study conduct

Overseeing site performance, recruitment progress, retention and data collection to ensure that timelines and quality objectives are met

Leading site training and providing continuous support on study protocols, systems and compliance requirements

Managing IMP, study supplies, essential documents and the Investigator Trial Master File to ensure accountability and compliance

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 are looking for a motivated and experienced clinical research professional who thrives in dynamic environments and is passionate about high-quality trial execution. To succeed in this role, you will bring:

A bachelor's degree in Life Sciences (preferably Biotechnology, Pharmacy, Chemistry, Biology or CTF)

A minimum of 3 years of clinical trial monitoring experience within the pharmaceutical industry or a CRO, with proven independence in monitoring activities and strong expertise in applying ICH-GCP E6(R3), clinical trial methodology, regulatory requirements, and SOPs. Proven ability to ensure risk-based quality management, patient safety, data integrity, inspection readiness, and regulatory compliance throughout the trial lifecycle. Valid GCP certification required.

Solid working knowledge of electronic clinical trial systems, including CTMS, EDC, IWRS and eTMF. Demonstrated digital mindset and willingness to actively leverage AI tools and emerging technologies to improve monitoring efficiency, data quality, and operational excellence.

Excellent stakeholder management, communication and negotiation skills, with the ability to build strong relationships across all organisational levels

Strong organisational and time management skills, attention to detail and a proactive approach to problem-solving and risk mitigation

Fluency in both Italian and English (written and spoken) and flexibility to travel on a monthly basis

Working at Novo Nordisk

A career in Research & Development at Novo Nordisk means your expertise will touch the lives of millions of patients living with serious chronic diseases. You will work alongside insightful, brilliant colleagues at the forefront of science, in a culture of curiosity, continuous learning and open collaboration. For over 100 years, our dedication has driven us to build a company focused on lasting change for long-term health - and when you join us, you become part of a story that spans generations.

What we offer

At Novo Nordisk, you’ll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage.

Salary

For this role, the Annual Base Salary ranges from 43,940.00 to 68,110.00 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 here.

Deadline

July 22nd, 2026