Study Start-Up CRA

Do you have experience with submissions and clinical trials monitoring? Would you like to join a great team of highly qualified professionals who are driving change? Are you eager to reach your fullest potential in a dynamic environment? If so, we might have the right opportunity for you! Apply today for a role as Study Start-Up Clinical Research Associate (SSU CRA) and embark on a new, life-changing career. 

As a Study Start-Up CRA, you will be responsible for effectively managing and executing start-up activities for assigned clinical trials, ensuring compliance with local regulations, Novo Nordisk procedures, and protocol requirements. Additionally, you will play a crucial role in establishing and nurturing professional relationships with both hospitals and internal stakeholders. 

The position 

• Manage and execute the start-up activities in the allocated clinical trial in compliance with EU CTR, local regulations, ICH-GCP, Novo Nordisk procedures and protocol requirements. 

• Manage and monitoring ongoing trials in start-up together with the LEAD CRA within selected timelines.

• Prepare documents for submission (including translation and redaction) and to handover the CTA package to EU submission HUB within selected timelines – completion of EMA templates, obtain local insurance certificate. 

• Check the completeness and correctness of all documents/materials for SIV in close collaboration with the LEAD CRA and Clinical Trial Administrator 

• Working in compliance with the local regulations, ICH GCP guidelines and Novo Nordisk procedures to ensure high data quality and study subject protection 

Qualifications 

Our ideal candidate is a detail oriented person who can deliver high-quality results while managing multiple projects and priorities. As our next SSU CRA, we expect you to have excellent communication skills and to enjoy building trust and maintaining relationships with key stakeholders.

Our ideal candidate: 

• Demonstrates excellent communication skills and is a team player with a flexible approach to meeting the needs of different trials to achieve established goals

• Holds a university degree in life science, medical sciences, nursing or equivalent and preferably a valid GCP certification·

• Has CRA experience in monitoring clinical trials in accordance with ICH GCP methodology or good knowledge of clinical trial methodology and the environment in which these are conducted·

• Has fluency in both spoken and written Swedish and English, as well as an understanding of scientific medical terminology, trial protocols, and other trial related documents. Additionally, you are capable of writing monitoring reports proficiently in both languages.

• Is willing to travel frequently to visit trial sites for monitoring and to attend trainings/meetings which may include overnight stays.

About the department 

The Swedish affiliate of Novo Nordisk has around 110 employees, half of whom are based in our Malmö office. As a CRA you are part of the Clinical Research Team within the Clinical, Medical and Regulatory Department in the affiliate, where you report directly to the Head of Clinical Research in Sweden and work closely with the international Trial Managers. The Clinical Research Team is responsible for conducting high quality clinical trials in Sweden within several therapy areas, building a solid ground for the future portfolio and for new and better treatment options for patients worldwide. It is an advantage but not a requirement that you live within commuting distance from Malmö. 

Working at Novo Nordisk 

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. 

Contact

If you are interested in this opportunity, please apply to the role via our online platform,

For further information please reach out to Head of Clinical Operations, Camilla Ranum Spohr at [email protected]/+ 4530791718. 

Deadline

Please apply before 7th July 2024 

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.