Clinical Trials Start-up and Submission Specialist – Clinical Development Centre

Job title:

Clinical Trials Start-up and Submission Specialist – Clinical Development Centre

Company:

Novo Nordisk

Job description

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Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading…Category×Select how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Clinical Trials Start-up and Submission Specialist – Clinical Development CentreCategory: Clinical DevelopmentLocation:Alphen aan den Rijn, Zuid-Holland, NLDoes your motivation come from challenges and working in a dynamic environment? Is your ambition to create visible results? Come be part of our team as we embark on an exciting journey of growth! Make a real impact with us, as a Clinical Trials Start-up and Submission Specialist at our recently established Clinical Development Centre (CDC) in the Netherlands.This is a hybrid role and you should be able to go to the office on a regular weekly basis.The PositionAs a Clinical Trials Start-up and Submission Specialist, you will lead, coordinate, and analyse (start-up) processes to obtain and maintain Health Authorities & Ethical Committee/ Institutional Review Boards approvals for assigned studies in accordance with local regulations, ICH-GCP, Novo Nordisk procedures and trial timelines.Key responsibilities include:Participate in kick-off meetings and trial TCs with the EU Submission Hub and CDC Trial Managers.Provide submission timelines and monitor and communicate critical issues that may impact trial progress during kick-off meetings and trial TCs with Regulatory Affairs CTA management, EU Submission Hub, and CDC Therapy Area Managers.Address any issues or concerns raised by regulatory bodies during the review process, working to resolve them promptly and effectively.Repeat start-up activities during the trial conduct: to prepare documents for submissions and notifications and handover to EU Submission Hub (incl. translation and redaction of new trials documents).Identify potential risks and proactively take action to prevent or mitigate.QualificationsTo be successful in this role, we expect you to have the following qualifications:Master’s level education and ≥5 years of previous experience in the healthcare industry, including clinical trials submissions.Basic GCP qualification.Professional proficiency in English and DutchExperience in taking ownership of start-up activities to ensure timely submission and FPFV, proactively flagging risks and issues and providing possible mitigations and solutionsStrong knowledge of clinical trial methodology, drug development process, and up-to-date understanding of ICH GCP and regulatory issues.You should also be open to an agile work environment, a strong team player and a responsible person who can combine a sense of urgency, proactivity with attention to detail.The DepartmentOur Clinical Development Centers, part of the Clinical, Medical and Regulatory Departments, are the backbone in clinical trials and have the benefits of strengthened partnerships and launches. We conduct clinical trials in more than 50 countries around the world, in close collaboration with our affiliates, regions and global teams.You will be a part of our large, resourceful development team that plays a crucial role in the ambitious drug development programs at Novo Nordisk. Our highly motivated team is composed of over 45 employees, and you will become a part of the ClinOps Excellence & Start up, reporting directly to the Head of ClinOps Excellence & Start up.Working at Novo NordiskWe 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 energize 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.ContactPlease submit your application via the Novo Nordisk website.DeadlineApply before 19 April 2024We 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.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.

Expected salary

Location

Alphen aan de Rijn, Zuid-Holland

Job date

Fri, 12 Apr 2024 01:09:12 GMT

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