Denmark Job Openings
Novo Nordisk
Senior Data Manager
Måløv
October 16, 2024
The position
You will coordinate and implement timely set-up of data management systems and handle all non-clinical study related documentation.
Your areas of responsibility will be:
- Responsible for timely delivery of high-quality project deliverables and coordination of data management processes in designated non-clinical study and submission sections.
- Ensure all tasks performed are given priority, conducted, and reported according to customer needs.
- Provide project activity overview to line of business. Prepare and review reports and ensure that validation and study data activities are properly finalized and reported.
- Ensure compliance with current Gx P (GLP and GCP) regulations, and the necessary innovative approaches are established for the team, to become a centre of excellence meeting regulatory requirements for handling study data.
- Continuously ensure that processes and programming used in the department always are state-of-the-art and that new approaches are implemented to meet current and future demands.
- Interact with members from external organizations, e.g. CDISC.
Qualifications
To thrive and succeed in this position we would expect you to have:
- A Ph D, MSc or BSc in computer science, information technology or natural sciences.
- A minimum of 3 years of experience as Data Manager.
- Preferably experience in the pharmaceutical industry, including Gx P knowledge.
- Experience with SAS and implementation of SEND (Standard for Exchange of Nonclinical Data), SDTM (Study Data Tabulation Model), or with running CDISC clinical studies is considered an advantage.
- Likewise, R and AWS infrastructure experience would be an advantage.
About the department
Digital Science & Innovation (DSI) is supporting the digital journey across all our therapy areas in R&ED. In DSI, we work in multidisciplinary teams – in strong collaboration with all areas across R&ED and DD&IT R&ED. We participate in drug development projects across the value chain, from early discovery to pre-clinical development. We engage in external collaborations to ensure access to the latest research and technology enablers, and we automate our labs and processes, and we focus on developing and retaining top talent.
Located in Måløv, Non-clinical Data Management is a part of Research Data Management in R&ED Digital Science & Innovation. Our main task is to handle data management activities in GLP or GCP regulated areas working with standardised data.
The implementation of SEND (Standard for Exchange of Nonclinical Data) requirements is anchored in our department where we have built a simple and effective SAS solution to meet the requirements and support the involved processes. Our department consists of ten data management colleagues and now we are looking forward to welcoming a new and ambitious colleague to our team.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
For further information, please contact Pia Jellinggaard, Director Non-clinical Data Management, at pjel@novonordisk.com.
28 October 2024.
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