Clinical Research Associate 1

1 settimana fa

Roma, Italia Novo Nordisk A tempo pieno

Do you want to join one of the leading companies of the pharma sector?

Do you want to build your career and contribute to the growth of the company?

If it sounds interesting to you, we have the right job

The Italian affiliate of Novo Nordisk, based in Rome, is hiring a Clinical Research Associate (CRA) 1. You will join our Clinical Operations Team and you will work in a hybrid work mode, being preferably domiciled in central or northern Italy.

**The Position**

The CRA is responsible for managing clinical trial sites at every stage of the clinical trial process in accordance with the Company’s policies and procedures, relevant legislation, and ICH GCP requirements, whilst maintaining the standards of the Novo Nordisk Way.

Main accountabilities of the role:

- Primary point of contact between site staff and Novo Nordisk, act as a site manager and an ambassador for the company and contributes to making Novo Nordisk the preferred partner in clinical trials.
- Overall site management, including site monitoring and remote monitoring as applicable
- Ensure that trial site staff are properly trained to conduct the trial(s), provide necessary training, and identify and flag any development areas and implement mitigations.
- Managing trial sites to meet patient recruitment and retention target, aimed at successful completion of the clinical programme.
- Contribute to or lead selection of sites, in collaboration with CDC and local colleagues such as Line Managers and Medical Affairs.

**Qualifications**

To be eligible for this role, you need to hold a bachelor’s degree in life science (preferably in Pharmacy, Chemistry, Biology, CTF) and to have a minimum of 1 year of relevant working experience in the role, being independent in monitoring activities.

You also meet the following requirements:

- You are Fluent in both Italian and English.
- Knowledge of clinical trial methodology
- Knowledge of the clinical trials environment - ICH GCP, regulatory issues, SOPs
- Good working knowledge of electronic clinical trials systems - CTMS, EDC, IWRS, electronic TMF
- Basic GCP qualification

**About the Department**

You will work in our Clinical, Medical and Regulatory (CMR) department at Novo Nordisk, that is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies, to providing medical education and collecting data to support efficacy and new product development, CMR is involved.

**Working at Novo Nordisk**

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales - we’re all working to move the needle on patient care.

**Deadline**

**Contact**

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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