- 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.
- 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
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Clinical Research Associate Pipeline - Rome, Italia - Novo Nordisk
Descrizione
Joining the CRA Pipeline
By applying for the pipeline, you will be considered as a potential match for CRA positions, which align with your background, skills and interests. We'll match your profile proactively to ensure you don't miss out on a life-changing career. In accordance with your experiences and depending from vacancy characteristics, temporary or permanent role can be proposed.
We'll match your profile proactively with relevant positions. Once a Hiring Manager shows interest in your profile, our Recruitment team will reach out to you and tell you more about the current position and invite you for the 1st Interview.
You will remain a part of the Pipeline for up to 6 months unless you withdraw your application. We kindly ask you to inform us or withdraw your application, if you get a new job, which will ensure fair recruitment process to everyone and spare you for us contacting you.
The pipeline is open for applications due to GDPR we close the pipelines after 6 months and send email notifications to all active candidates when they are closed, with a link to where you can re-apply to our new CRA Pipeline.
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:
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 minimum of 1 year of relevant working experience in the role, being independent in monitoring activities. You also meet the following requirements:
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.
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.
