stillingsbetegnelse: Senior Standards Supporter

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 experience and quality mind-set bringing clinical projects to registration and market? Then you may be our new colleague. 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 27 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 a Senior Data Standards Supporter you will be focused on defining and maintaining clinical metadata standards in the Global Library of our clinical database (Oracle Clinical) and maintaining standards for CRFs according to e.g. CDISC standards. With the implementation of CDISC standards at Novo Nordisk, our standard CRF library will be growing. The Senior Data Standards Supporter will be involved in designing new standard CRFs, specifying standardised end-to-end mapping of data from the point of data collection to SDTM datasets, and implementing the standards across our systems. Along with the introduction of CDISC there is an increased focus on the control of standards, and the Senior Data Standards Supporter will play an important role in this. We continuously initiate new improvements and you will have opportunities to develop project management skills, conduct training sessions and make presentations. We expect you to take part in developing, enhancing, and maintaining documentation and processes related to our clinical systems and standards. 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. Qualifications You have a B.Sc. or M.Sc. within IT, natural sciences or other relevant degree and at least three years of experience working with clinical data in the pharmaceutical industry, preferably with a focus on CRF design and trial set-up in Oracle Clinical. You are technically strong, have a demonstrated ability to understand data structures, possess knowledge of relational databases, and are proficient in SQL programming. You have excellent collaboration and coordination skills.You have high attention to detail, an analytical approach, and you thrive when performing careful meticulous work. Furthermore, you have good communication skills and are comfortable working in English on a daily basis (both spoken and written) in a global organisation. You are capable of working independently, taking responsibility, and showing initiative. We expect you to be able to maintain an overview several tasks in parallel without compromising the quality of your work and that you remain high spirited, also when things are moving fast. Additional desirable skills are experience with project management, CRF design, CDISC standards, OC set-up, clinical data warehouse, SAS programming, statistical analysis, and knowledge of

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