stillingsbetegnelse:
Clinical Data Standards Specialist with CDISC and CDMS experience

jobbeskrivelse:
- Biostatistics and Data Management - Denmark - Søborg 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. Do you wish to work in a highly professional, engaged and global environment where you can use your clinical data skills and quality mind-set bringing clinical projects to registration and market? You may be one of our new standards specialists. 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 Data Management Standards and Support is part of Clinical Operations, and consists of 22 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 data 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 develop and maintain global CRF and data base standards in Novo Nordisk’s clinical IT systems in alignment with external data standards (CDISC). As part of the daily work the Standards Specialist support clinical trial teams in the use of standards and acts as a mentor for the Standards Supporters in technical problem-solving as well as process support. The Standards Specialist will also participate and drive improvement projects related to standards e.g. implementation of CDISC controlled terminology and SDTM data model in the standards. The Standards Specialist is a role model in stakeholder management and is able to communicate effectively with diverse stakeholders, which includes Data Managers, Biostatisticians, Statistical Programmers, Trial Managers and others within clinical development. The Standards Specialist will actively share best practices across the organisation and provide targeted training in areas of expertise. Qualifications You have a B.Sc. or M.Sc. within IT, natural sciences or other relevant degree as well as in-depth knowledge and experience working with clinical data standards in the pharmaceutical industry. You have high experience working with standards within clinical IT systems (EDC, CDMS and CDW), relational databases, standards governance, CDISC and clinical data domains. We expect you to have at least 5 years’ experience within clinical research, within e.g. data management or biostatistics. You have a proven ability to understand and communicate with stakeholders in Data Management, Biostatistics, and Trial Management, including the ability to provide targeted training in our systems and processes. You are a driver, show initiative, work independently, seek guidance when needed, and take responsibility for delivering high-quality results on time. Furthermore, you are comfortable working in English on a daily basis (both spoken and written) in a global organisation. You have very strong cooperative and analytical skills and excellent coordination skills. We expect you to be able to maintain an overview of several tasks in parallel without compromising the quality of your work and that you remain high spirited, also when things are moving fast. In return we offer an interesting and challenging job with a high degree of individual r

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark