Clinical Data Standards Specialist

Do you want to work with standardising data in clinical trial? Are you looking to make significant contributions to securing the success of Clinical Trials (CT)? Would you like to ensure that the collected clinical trial data is meaningful from a scientific perspective?

If you are eager to develop and maintain data standards in CT, this presents an ideal opportunity to actively contribute to our ever-evolving data science community. Don't hesitate—apply today and join us in making a difference!

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  

The position will be based in either Aalborg or Søborg.

Qualifications

To thrive in this role you:

• Hold a minimum of a university degree within IT, natural sciences or other field of relevance with post-graduate qualifications preferred
• Bring strong experience within clinical or scientific research and/or working with data and metadata in clinical studies.
• Approach tasks with a with a high level of scientific rigor and demonstrate a willingness to continuously upskill yourself.
• You are fluent in oral and written English.
• As a person 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. 

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

To hear more on the position, you are welcome to contact Steffen Nørgaard Vangsgaard, Director, Data Systems and Standards at SFVN@novonordisk.com or Michael Corazza, Manager, Data Systems & Standards at MHCZ@novonordisk.com.

Deadline

May 12th, 2024

We are performing on-going screening of candidates so upload your CV today. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

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.