Data Management Expert for Non-Clinical Studies

6 hours ago

Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time
Job Overview

We are seeking an experienced Data Management Expert to join our team in Novo Nordisk A/S's Research Data Management department. The successful candidate will be responsible for managing non-clinical data flows, ensuring high-quality project deliverables, and collaborating with internal and external partners.

About the Role

The Senior Data Manager will work closely with colleagues and partners across different non-clinical disciplines, coordinating and implementing timely set-up of data management systems, and handling all non-clinical study-related documentation. Key responsibilities include:

  • 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 GxP (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 PhD, 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 GxP 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.
Salary and Benefits

The estimated salary for this position is approximately $85,000-$110,000 per annum, depending on location and qualifications. We offer a competitive benefits package, including health insurance, retirement savings plan, and generous paid time off.

Why Join Our Team

In Digital Science & Innovation, 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.

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