stillingsbetegnelse: Standards Supporter

jobbeskrivelse:
- Biostatistics and Data Management - Denmark - Søborg Then join the 24 enthusiastic experts in our department, Data Management Standards & Support (DMSS). We need 2 new Standards Supporters to help us support the use and governance of our clinical data standards, and take part in shaping the future CDISC standards processes of Novo Nordisk. About the department Our main focus is to support the use and governance of our clinical data standards across multiple systems used for data collection and reporting of our clinical trials. We assist trial teams in standardisation throughout all phases of the trial and work closely with multi-functional and international teams on a variety of clinical and technical projects in a pleasant and informal atmosphere. We are dedicated to CDISC and currently implementing controlled terminology and SDTM across multiple systems used for data collection and reporting of our clinical trials. We are a dynamic department which cooperates with many different professionals in the organisation both within Denmark and across borders with our affiliates in the US, India, China and Japan, as well as our outsourcing partners in India. The job The two positions may be individually composed by any number of the department’s main responsibilities Support trial teams during setup, conduct and closure of their trials and advise in the use of clinical data standards in all phases. This may entail activities such as review (e)CRFs and database annotations to ensure conformance with standards as well as handling of requests for new objects in relation to trial specific database build. Contribute to the innovation of the clinical data standards and maintenance of the Global Library in compliance with CDISC. This includes documentation of the processes related to our clinical data standards. Ensure standardised flow of data through the three systems used for data handling in Novo Nordisk’s clinical trials: Electronic Data Capture (InForm), Oracle Clinical (OC), and our Clinical Data Warehouse (CDW). Handle mapping of data to the Clinical Data Warehouse (CDW). Take part in the CDISC project contributing to design of the new SDTM and controlled terminology systems, tools and processes. Work closely with Data Managers, Biostatisticians, Statistical Programmers, Trial Managers and others within clinical development to ensure standardised, GCP compliant, quality clinical trial data across our systems. Qualifications You have extensive knowledge and experience with clinical data in the pharmaceutical industry, and have a B.Sc. or M.Sc. within IT or other relevant degree. Relevant experience in dealing with GCP data in the pharmaceutical industry is a pre-requisite. You also have experience working with standards within clinical IT systems (EDC, CDMS and CDW), relational databases and standards governance. You are technically strong and have a demonstrated ability to understand data structures, high attention to detail, and you thrive doing careful meticulous work. Strong cooperation and analytical skills are a necessity, and SAS programming competencies is an asset, as is experience with the CDISC standards. You are service-minded and capable of working independently, taking responsibility, and showing initiative. You are able to make complete and thorough documentation. We expect you to be able to overview several tasks in parallel without compromising the quality of our work and that you remain high spirited, also when things are moving fast. We have daily cooperation with colleagues based in India, so fluent English is a must – both written and spoken. In return we offer an interesting and challenging job with a high degree of individual responsibility as well as good personal development opportunities in an international atmosphere. The positions are located in our office building on Vandtårnsvej 114, Søborg, Denmark. At Novo Nordisk, your skills, dedication and ambition help us change live

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