Specialist for Data Standards Management
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Søborg
- Clinical Development and Medical
- Søborg
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 Specialist.
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
You will be 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.
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 within engineering, IT, natural sciences or other field of relevance and at least 5+ years of experience working with IT systems, processes, standards and programming related to clinical studies and clinical data management.
You have hands-on programming experience with data analytics, dataflow automation, data visualisation and metadata management in the pharmaceutical R&D space. Alternatively, you have in depth experience with study build in Central Designer, Data Management Workbench or standards management in off-the-shelf MDR system. You also preferably have experience with SAS programming and SAS Stored Processes. You are confident in your ability to learn new technologies and can demonstrate it through your work experience.
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 benefit.
You have a strong interest in natural sciences that can help you understand biomedical concepts and clinical study protocols and are skilled in translating clinical and scientific requirements into data collection standards and tools.
You have an analytical approach to tasks and an ability to quickly grasp the overview and inter-relationship of discrete systems and processes. 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 work independently when required, take-on responsibility and show initiative. Your work experience can demonstrate examples of project leadership and ability to deliver in a cross-organisational project team.
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
31 January 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.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 20.12.2019, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg
- Torsdag den 31. januar 2019
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