Novo Nordisk
CRA- Cardiovascular Diseases
We are looking for a CRA’s to join our team. As a CRA working with Novo Nordisk’s Clinical Development Centre, you will have the opportunity to make a difference to patients’ lives. This position is particularly focused towards Cardiovascular Diseases. 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.
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