stillingsbetegnelse:
Experienced Data Manager for setting up non-clinical data flows

jobbeskrivelse:
- Research & Development - Denmark - Måløv Our growth is your opportunity Being part of Novo Nordisk Research & Development means working at one of the world's largest and most successful biopharmaceutical companies. Our R&D organisation is vital to Novo Nordisk's continued growth and we always welcome talented people who would like to grow with us. We are seeking a new colleague to take up one of the first non-clinical data manager positions for the coordination of electronic data capture from non-clinical studies - in order to comply with new FDA submission requirements. Are you burning to build data management from scratch in an area unfamiliar with working with standardised data, i.e. with electronic data capture, non-clinical data management systems, non-clinical standards and biological data? Do you want to be a key player in the drug development process ensuring future submissions? Do you like to work with leading technology and processes? If so, you could be our new colleague in Quality & Systems Management - a department within the pre-clinical area of Global Research - which now expands to cover non-clinical data management of submission data. The Global Research Unit specialises in the discovery of biological medicines for the treatment of type 1 and 2 diabetes. We also discover and develop new innovative biopharmaceuticals for haemophilia and growth disorders. Furthermore, we conduct stem cell and beta cell regeneration research and other early-stage investigations aimed at finding a cure for diabetes, as well as exploring novel treatments for obesity and long-term, micro-vascular complications of diabetes. The Global Research Unit consists of app. 1500 highly qualified Scientists, PhDs/PostDocs and Lab Technicians and we conduct our world class research from sites based in the Greater Copenhagen area, Beijing and Seattle. About the department Located in Måløv, Quality & Systems Management is part of Non-clinical Development and we work in a regulated area (GLP and GCP). SEND (Standard for Exchange of Nonclinical Data) implementation is anchored in our department, which already consists of a systems management group supporting laboratory computer systems (2-30 users) as well as data management systems (10-60 users). The new data management group will to a large degree collaborate with the approximately 10 colleagues already supporting our IT systems. The job As data manager you will be responsible for ensuring the many systems we use for collecting data from our non-clinical studies are correctly linked so there is a proper and timely flow of data to our yet-to-be-built non-clinical data repository. You will be part of our cross-functional SEND team and be a key driver in defining the processes of future data captures as well as standard procedures for submission of the data. Our department will be working closely with internal as well as external partners and you will need to establish a broad and daily contact with colleagues and partners within different non-clinical disciplines. Areas of responsibility for you as data manager will be coordination and timely set-up of data management systems and therefore a solid understanding of IT systems and processes will become required. Furthermore, strong project planning and change management skills are necessary. It is expected that you can handle all non-clinical study related documentation as well as have a good understanding of how data are used. Qualifications You have a BSc or MSc within IT, natural sciences or other relevant degree and extensive knowledge and experience from the pharmaceutical industry, including GxP knowledge. Experience with implementation of SDTM (Study Data Tabulation Model) or with running CDISC clinical studies is considered an asset. You have excellent overview, presentation and coordination skills. Furthermore, good English skills, and strong cooperation skills are necessities for holding the p

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Systemanalytikerarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark