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stillingsbetegnelse: Talented Professional for Standards Development

jobbeskrivelse:

Do you wish to experience a highly professional and engaging global environment bringing clinical projects to market standards? Do you want to apply your skills and quality mind-set in translating regulatory requirements and business needs into efficient and fit-for purpose data standards, processes and tools to support clinical trials? Then our department offers an exciting opportunity as a Standards Developer.

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.

 

About the Department

Our department, Clinical Data Standards, is a part of Global Development, and consists of 28 enthusiastic and highly engaged people with both broad and specialist knowledge. We work closely with multi-functional and international teams on a variety of clinical and technical projects in a pleasant and informal atmosphere.

 

Our main responsibility is to develop and maintain efficient data collection & reporting standards for clinical data, and to support their use in generating data and documentation that is compliant to regulatory data standardisation requirements.

 

The position

As a Standards Developer, your primary task will be to support the ongoing management of standard library components and metadata across the data collection and reporting continuum. Based on your skill set and experience, your tasks will focus on one or more of the following areas:

 

• You will help define, develop and implement CDASH/SDTM compliant data collection systems, and support in the review and publishing of new standards.

   

• You will help research external requirements and industry best practices (either in the use of systems or in regulatory requirements like CDASH, SDTM and ICSR) to identify improvement opportunities of our processes and provide expert input for enhancing our standards.

   

• You will promote the proper application of standards in our clinical trials by actively supporting in the standards governance process, by providing just in time training, and by developing and maintaining relevant tools and quick guides.

 

Depending on your specific tasks, you will have close collaboration with primary stakeholders such as Biostatistics, Data Management, SDTM programmers and Trial Management.

 

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

February 17, 2019 

 

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.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2512

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: Novo Nordisk A/S

source: DK-STAR