stillingsbetegnelse:
Experienced Specialist for management of Clinical Data Standards

jobbeskrivelse:
- Biostatistics and Data Management - Denmark - Søborg Do you wish to work in a highly professional, engaged and global environment and use your skills and quality mind-set in bringing clinical projects to registration and market? Do you like a challenging and rewarding workplace having a broad contact with colleagues and partners from around the globe? 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. About the department The department Clinical Data Standards is part of Clinical Operations, and consists of 28 enthusiastic and highly dedicated people working in an inspiring and ambitious working 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 position The Standards Specialist drives the development of data standards, supports their maintenance in various clinical data management systems and their use in different clinical projects across various phases of our clinical trials. You will be exposed to a variety of challenging and exciting activities working in a global environment and closely collaborating with primary stakeholders such as Biostatistics, Data Management and Trial Execution as part of your task to define optimal data standards for clinical projects in Novo Nordisk. You will manage the development process to ensure timely release of data standard components in alignment with business needs and regulatory requirements, for example CDISC SDTM. You will be involved in all stages of analysis, specification, process design and implementation as well as change management and training. Novo Nordisk offers treatment to patients across different therapeutic areas, which is reflected in the variety of clinical trials and the clinical data management systems we have. Hence, you will apply your talent for developing new solutions within a complex and a highly regulated environment and your capacity to work with complex processes and IT systems. Results are normally achieved through collaboration in global teams; hence the job requires project management skills, good attention to detail and the ability to manage complex and critical communication in a timely fashion. Some amount of travel will be expected in relation to travel to our affiliates in Bangalore, India and participation in international conferences. Qualifications We expect that you have a degree within IT, Natural Sciences or other relevant degree, preferably a B.Sc or M.Sc in Medicine, Nursing, Pharmacy, Veterinary Science, or Clinical Information Management. Practical experience of at least 5 years from the pharmaceutical industry and GCP knowledge as well as experience working with clinical trial processes and clinical data is expected. Experience with data standards governance in a large, global organisation as well as CDISC standards is an advantage. You have excellent overview, presentation and coordination skills. Furthermore, good English skills, strong cooperation and analytical skills are necessary. You are capable of working independently, taking on responsibility and showing initiative. You are also capable of coordinating tasks among stakeholders and collaborating to deliver timeline critical projects to expected quality. We expect you to be able to overview several tasks in parallel without compromising the quality of your work and that you remain high spirited, also when things are moving fast. Working at Novo Nordisk In Novo Nordisk your skil

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