stillingsbetegnelse: Non-clinical Data Manager

jobbeskrivelse:
- Research & Development - Denmark - Måløv Are you burning to become part of a pioneering data management group building up data management processes 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 that now expands further to support non-clinical data management of submission data - in order to comply with FDA submission requirements. 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). The implementation of SEND (Standard for Exchange of Nonclinical Data) requirements is anchored in our department. The department consists of a systems management group of eight as well as a small data management group of five colleagues. The job As data manager you will be responsible for the non-clinical data flow through the systems we use for collecting data in-house and for reception of data from contract research organisations (CROs) to our yet-to-be-built non-clinical data repository. You will be part of our cross-functional SEND team and be a key player in implementing processes of future data collection from in-house laboratories and CROs 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, 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 preferably knowledge and experience from the pharmaceutical industry, including GxP knowledge. Experience with SAS and 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 a data manager position and you must be able to work independently, take on responsibility and show initiative. Working at Novo Nordisk We always strive for excellence and continuously develop our expertise to stay ahead - both as a company and as individuals. And we believe innovation and creativity thrive in a healthy and engaging working environment. We are a friendly group looking for someone with an open and analytical personality, who is flexible and positive towards the challenges which this position will bring - and determined not to compromise on quality. Contact For further information, please contact Pia Jellinggaard on +45 3075 6886. Deadline 3 March 2016.

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