Talented academic professional for data standards development

Novo Nordisk A/S

Fuldtidsjob
Storkøbenhavn

Category:

Clinical Development & Medical

Location:

Søborg, Capital Region of Denmark, DK

Do you wish to experience a highly professional and engaging global environment bringing clinical projects to market? Do you want to apply your skills and quality mind-set in translating regulatory and business needs into fit-for purpose data standards, or apply your flair for technology into adapting our standards and tools to the evolving e-clinical landscape? Then our department offers an exciting opportunity as a Standards Developer.

About the Department

In Global Development, we are responsible for managing clinical drug development worldwide, ensuring that the process lives up to uniform global standards, regulations and business ethics while delivering viable products that make a difference to patients and ultimately benefit society.

Our department, Clinical Data Systems and Standards 2, is a part of Global Development and consists of 11 enthusiastic and highly engaged people with both broad and specialist knowledge.

The Position

Our department is responsible for developing and maintaining an efficient set of data collection & reporting standards, systems, processes and tools used in the generation of regulatory compliant clinical data. We work in multi-functional and international teams on a variety of clinical and technical projects across trial operations, data management and biostatistics. The position offers a unique opportunity to gain valuable experience and insight across a broad set of functions in the drug development process.

Based on your skills and experience, your tasks will focus on one or more of the following areas:

  • Define and develop CDASH/SDTM compliant clinical data standards, and support in their continuous improvement.
  • Research external and internal requirements and industry best practices (either in the use of systems or in regulatory requirements like CDASH, SDTM and ICSR) to identify improvement opportunities and provide expert advice to the organisation
  • Improve our processes and systems through leveraging new and existing technology solutions.
  • Support our clinical studies in ensuring compliance to business requirements, and use of standards and systems, through expert advice, just-in-time training and system implementations.

Qualifications

You hold a university degree within IT, natural sciences or other field of relevance. You have an analytical approach to tasks and an ability to quickly grasp the overview and inter-relationship of discrete datatypes and related systems. You have good experience programming in one or more technologies, and you are confident in your ability to learn new ones. Ability to manage complex and critical communication in a clear, concise and timely fashion is a must, and experience with structured authoring is a benefit. Fluency in oral and written English is essential.

You have high attention to detail and thrive when performing careful meticulous work. You are able to work independently, take on responsibility and show initiative.

On a personal level, you are team oriented and enjoy working with people from different professional backgrounds. You are eager to see things moving forward and possess a certain drive to make things happen which has a positive and motivating effect on your team members.

Working at Novo Nordisk

In Novo Nordisk your skills, your commitment and your ambitions help us to improve many people's lives. In return we offer an interesting and challenging environment where you will work with exceptionally talented colleagues and have a high degree of individual responsibility and a wide range of opportunities for professional and personal development.

Contact
For further information, please contact Tom David at +45 30 79 05 31.

Deadline
1 November 2019.

Please do not hesitate to apply. Applications will be evaluated as they are received.

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.


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Ansøgningsfrist d. 01.11.2019
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Fuldtidsjob
Storkøbenhavn
IT
Medicinal & Sundhed
Naturvidenskab
Teknik & Teknologi
Data & analyse
Forskning & Udvikling
IT - Software
Medicinal & Sundhed



Novo Nordisk A/S - hurtigt overblik


Novo Nordisk A/S
Novo Nordisk A/S
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity.

Placering
Novo Allé
2880 Bagsværd
Logo: Novo Nordisk A/S
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https://jobbank.dk/job/1397917/