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Novo Nordisk

Senior Data Manager

Fuldtid

Permanent

Novo Nordisk Park 1, 2760 Måløv, Danmark

SE PÅ KORT
ID: 2739164
|
Indrykket for 4 dage siden

Do you want to be a key player in the drug development process ensuring future submissions, and are you passionate about data management? Are you motivated by handling multiple stakeholders and several tasks at the same time? Then you may be the next member of our team. Take the next step in your life-changing career and join us in Non-clinical Data Management.
 
The position

As a Senior Data Manager, you will be responsible for the non-clinical data flow through the systems we use for collecting data in-house and for the reception of data from contract research organisations (CROs) to our non-clinical data repository. You will work closely with internal as well as external partners and hence, having broad and daily contact with colleagues and partners within different non-clinical disciplines.
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 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.
  • On a personal level, you possess strong cooperation skills while being able to work independently. You are a strong coordinator, who is good at keeping an overview of several processes at once. You take on responsibility and show initiative to drive new successes. Furthermore, you are a strong communicator, who speaks and writes English fluently.
     
    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.
     

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