stillingsbetegnelse:
Clinical Data Standards Specialist with CDISC Experience

jobbeskrivelse:
- Biostatistics and Data Management - Denmark - Søborg Being part of Novo Nordisk Research & Development means working at one of the world's largest and most successful biopharmaceutical companies. Do you wish to work in a highly professional, engaged and global environment where you can use your clinical data expertice and quality mind-set bringing clinical projects to registration and market? Then you may be our new Standards Specialist. In Global Development we are responsible for managing clinical drug development worldwide from early development phases to product introduction. We ensure medical and scientific documentation for clinical submissions and authorities while ensuring that the process lives up to uniform global standards, regulations and business ethics. We work in global project teams with focus on delivering viable products that make a difference to patients and ultimately benefit society. About the Department The department Clinical Data Standards is part of Clinical Operations, and consists of 26 enthusiastic and highly dedicated people working in an inspiring and ambitious work environment. Our main task is to develop and support the use of clinical data standards across multiple systems used for specification, collection and reporting of our clinical data. We work closely with multi-functional and international teams on a variety of clinical and technical projects in a pleasant and informal atmosphere. The job As Standards Specialist your primary focus will be to support the implementation of CDISC standards in Novo Nordisk. You will be a key person in the creation of Novo Nordisk’s version of the SDTM data model and contribute to the specification of standardised end-to-end mapping of data from the point of data specification to SDTM datasets. You will work in a global environment and have close collaboration with primary stakeholders such as Biostatistics, Data Management and Trial Execution in order to define optimal data standards to be used across clinical projects in Novo Nordisk. The job will give you a central role in Novo Nordisk’s implementation of CDISC in the global organisation and expose you to a variety of challenging and exciting activities. You will be involved in analysis, specification, process design and implementation as well as change management and training. You will have plenty of opportunities to work hands-on in our clinical data systems, e.g. Oracle Clinical (OC), Clinical Data Warehouse (CDW) and Metadata Management Application (MMA). Your position will make you a role model in stakeholder management and communication and offer a global platform for best practices sharing across the organisation. You will be expected to travel regularly to our affiliates in Bangalore, India and Princeton, US and participate in international conferences. Qualifications You have a B.Sc. or M.Sc. within IT, natural sciences or other relevant degree as well as substantial practical experience from a position within the pharmaceutical industry. You are familiar with CDISC’s standards governance procedures, and experienced with impact assessing and handling releases of new SDTM versions or Controlled Terminology. You are well versed in the SDTM data model, and you have experienced the challenges of implementing this in a complex context of clinical IT systems (EDC, CDMS and CDW, SCE). You have experience with data standards governance in a large, global organisation, and you are aware of the downstream implications for the stakeholders in the dataflow when new standards are implemented. You are an experienced trainer with the ability to facilitate complex topics to a variety of target groups, and you can document this qualification with several experiences in planning and executing training sessions for both large and small audiences. You can design courses as per need, create training material and plan the logistics around the practical execution of both classroom and web-based train

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