Study Start-Up CRA

3 days ago

Malmö, Sweden Novo Nordisk Full time

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 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.

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