Standards Specialist

Fuldtid

Permanent

Alfred Nobels Vej 27, 9220 Aalborg Øst, Danmark

ID: 2585285

Indrykket for 10 dage siden

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.

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