Standards Specialist
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Are you ready to shape clinical trials' success? Can you ensure data quality and precision? Want to contribute to the development and maintenance of data standards used to collect data in clinical trials? Then look no further! This is an exciting opportunity where you will be able to contribute to our continuously evolving data science community. Apply now and join us! You will be making significant contributions to securing the success of the clinical trials in Novo Nordisk. The position The position offers a unique opportunity to expand your experience through working in multi-functional and international teams on a variety of clinical and technical projects that span several functions in the drug development value chain. As a member of our team, you will have a diverse set of responsibilities that revolve around the development and use of data standards to support the efficient execution of our global clinical studies. Your responsibilities can be broadly grouped as follows: Define and develop clinical data standards that are compliant with requirements from regulatory agencies (e.g. CDISC, ICH), cater to the operational and scientific requirements in our studies, and support in their continuous improvement
Research and engage in external and internal industry best practices in clinical study management to identify and implement improvements and provide expert advice to the organisation in the business processes we operate in
Collaborate with internal scientific and patient communities engaged in our clinical programmes to explore and translate the clinical science behind our product research into clinical data standards necessary for our clinical studies
Support our clinical studies in ensuring compliance to business requirements
Qualifications You hold a minimum of a university degree within IT, natural sciences or other field of relevance with post-graduate qualifications preferred
You bring strong experience within clinical or scientific research and/or working with data and metadata in clinical studies.
You approach tasks with a with a high level of scientific rigor and demonstrate a willingness to continuously upskill yourself.
You take responsibility and work independently when required in a fast-paced environment with many stakeholders and parallel projects. You are detail-oriented and take pride in delivering high-quality results and can grasp complex processes and systems.
Knowledge of CDISC standards such as SDTM and CDASH is a plus.
You are fluent in oral and written English.
About the department In Novo Nordisk Development, we manage clinical drug development worldwide, ensuring that the process lives up to uniform global requirements, regulations and business ethics while delivering viable products that make a difference to patients and ultimately benefit society. Our department, Data Systems and Standards, is a part of Development and consists of 17 enthusiastic and highly engaged people. 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 energies 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 For any questions related to the position, please contact Michael Corazza, Manager Data Management Systems & Standards, at +45 30777096. Deadline 15 January 2024. Applicants will be screened on an ongoing basis. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. In addition, please avoid the use of photos in your CV. This makes for a better and more fair process. 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 "Softwareudvikler", og befinder sig i kategorien "Informationsteknologi".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 22.12.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Softwareudvikler
- Søborg
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