Clinical Research Associate

3 giorni fa

Rome, Italia Novo Nordisk A tempo pieno

   

Are you passionate about managing clinical trial sites and ensuring adherence to regulatory requirements? Do you want to contribute to making Novo Nordisk the preferred partner in clinical trials? If so, we have an exciting opportunity for you to join our team as a Clinical Research Associate (CRA). Apply today for a life-changing career.

 

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 Biotechnology, Pharmacy, Chemistry, Biology, CTF) and to have a working experience of a minimum of 1 year of independent monitoring. You also meet the following requirements:

  • You are Fluent in both Italian and English;

  • Knowledge of clinical trial methodology;

  • Good communication skills;

  • 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
CDC Italy is part of Region South East Europe, Middle East and Africa (SEEMEA) and is a new set-up of clinical organization in Novo Nordisk Italy. CDC Italy is responsible for conducting clinical trials within the country, providing clinical trial management and administration supporting the local teams.
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.
In relation to Clinical Operations Italy is organised with a dedicated Clinical Development Centre (CDC) which is part of the CMR department.
 
Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear, and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing.
 
Contact
If you believe you are qualified, and cannot wait to take the challenge, please upload your motivation letter, CV and relevant documentation directly via our online application tool.

 

Deadline 

Apply before July 1, 2024. 


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.


Please apply to the role via our online platform, as we don’t accept directly sent CVs. 

 

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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