Clinical Research Associate (CRA)

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Ørestad

We are looking for two CRA’s to join our team. As a CRA working with Novo Nordisk, you will have the opportunity to make a difference to patients’ lives. These positions are particularly focused towards Diabetes and Obesity. If you are eager to make a real impact, and you are ready for a fulfilling career, this may be the perfect opportunity for you. Don’t hesitate any longer and apply to the role! The Position In this exciting role you will manage clinical trial sites at every stage of the clinical trial process to a high quality in accordance with the Company’s policies and procedures, relevant legislation and ICH GCP requirements whilst maintaining the standards of the Novo Nordisk Way. You will collaborate closely with clinical investigative site teams to deliver our clinical trials according to target. You will be accountable for data integrity, quality, patient safety and protection, regulatory compliance for all assigned sites, compliance to protocols, adherence to Good Clinical Practice, Clinical Trial Legislation, and local ethics requirements, as well as Novo Nordisk standard operating procedures (SOPs). In addition, you will be:
  • The main line of communication with Investigator site teams
  • Conducting and documenting monitoring visits in accordance with the Monitoring Plan and Risk Indicator Reports, using risk-based quality principles
  • Driving activities with sites to achieve recruitment and retention targets
  • Managing of protocol compliance, IMP handling and data entry requirements at site
    • Travel will be required approximately 30% of the time including some overnight stays depending on the clinical site’s location. Qualifications You are a very collaborative team player who is proactive and ready to help in challenging situations. You got a previous experience of monitoring trials in accordance with ICH GCP methodology as well as healthcare industry knowledge or customer service-based employment. Moreover, you have the following requirements:
  • Bachelor's Degree level, life science or nursing qualification or other relevant experience and an excellent understanding of clinical trial procedures – ICH GCP, regulatory issues, SOPs
  • GCP Certification
  • Knowledge of drug development process
  • Good working knowledge of electronic clinical trials systems – Veeva Vault, EDC, IWRS, electronic TMF
  • Excellent level of Danish and English
    • About the Department Novo Nordisk’s Danish affiliate has 5 clinical therapy areas (TAs) and each area has a dedicated team of Trial Managers, Clinical Research Associates and Clinical Trial Administrators. There are currently 18 CRAs across the areas who form a strong CRA community. Each TA has a specific clinical focus and is responsible for conducting high quality clinical trials in Denmark. We are part of a regional team of 8 countries and work closely with global Trial Managers. Our department has a very open and honest culture with a fantastic team spirit. We work hard, but always finds time to have fun together. 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. Contact If you have any questions, please contact Head of Diabetes TA, Shelley Brigstock +45 30750209 [email protected] or Head of Obesity TA Christina Rønsholt +45 30753220 [email protected]. Deadline Please, apply before 20 December 2023 You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. 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.


    Information og data

    Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".

    Arbejdsstedet er beliggende i Ørestad.

    Jobbet er oprettet på vores service den 5.12.2023, men kan have været deaktiveret og genaktiveret igen.

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    • Forretningsudvikler
    • Ørestad
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