Specialist for clinical data standards management

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.
 
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 12 enthusiastic and highly engaged people with both broad and specialist knowledge.


The Position

The Standards Developer is responsible for the creation and maintenance of efficient sets of clinical data collection & reporting standards, and their use in the generation of regulatory compliant clinical data. The role has in-depth knowledge of clinical data management, clinical study operations and regulatory requirements to clinical data, and leverages collaboration with other specialists to develop and deliver effective solutions and services to our clinical study teams.

The position will specialise in the development of our early phase clinical programmes and will cater to our fast-paced clinical studies with timely service of high quality. The position will also be deeply involved in incorporating next-generation tools and innovations into our standards management and clinical study setup processes.

The position delivers to several multi-functional and international teams on a variety of clinical and technical projects across trial operations, data management and biostatistics, hence offers a unique opportunity to gain diverse experience and valuable insight across a broad set of functions in the drug development process.


Qualifications

You hold a university degree, preferably within natural sciences, and in-depth operational experience in data management (or equivalent) that demonstrate skills and knowledge required to translate clinical and scientific requirements into data collection standards and tools. 


You have good awareness of the pharmaceutical regulatory environment and understanding of  ICH GCP and GXP requirements. Practical experience with CDISC standards or other data standards and data interchange formats in the pharmaceutical industry (for example HL7 FHIR standards) would be a great benefit.


You have a strong interest in natural sciences that can help you understand biomedical concepts and clinical study protocols. Any experience with data analytics or metadata management in the pharmaceutical R&D space can provide you with the edge to quickly grasp and adapt to the terminologies and ontologies that we apply to our standards management process. 


You are confident in your ability to learn new technologies and can demonstrate it through your experience. Programming experience or proven aptitude for technology would be a significant advantage, as Standards Developers work with several databases that support SQL, data lakes accessed using Python, data formats in SAS datasets and xml, and Office 365 Power Suite apps and tools. 


You have an analytical approach to tasks, have high attention to detail and an ability to quickly grasp the overview and inter-relationship of discrete systems, processes and clinical protocols. You use this skill to build up practical experience and standardised artefacts that allow you to quickly and efficiently deliver services to subsequent clinical programmes and studies.


You work independently when required, take-on responsibility and show initiative. You are comfortable working in a fast-paced environment and capable of adapting and planning your tasks around changing priorities while delivering meticulous work to expected quality. 


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


Deadline
31 January 2021. 

 

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 chronic 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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