stillingsbetegnelse: Lead Trial Data Manager

jobbeskrivelse:
- Biostatistics and Data Management - Denmark - Søborg Are you interested in working with Electronic Data Capture, Clinical Data Management Systems, clinical standards and biological data? Do you want to be a key player in the drug development process? Do you like to work with leading technology and processes? Do you like a challenging and rewarding workplace? Do you like having a broad and daily contact with colleagues and partners from around the globe? Then a role in the DM Operations department of 40 data managers is for you. 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 DM Operations is responsible for ensuring the many systems we use for collecting data for our trials are correctly linked so as there is a proper and timely flow of data to our Clinical Data Warehouse. Our department is working closely with internal as well as external partners. We are seeking a new colleague to take up the position as Lead Trial Data Manager. The working place will be our office building in Søborg. The job The Lead Trial Data Manager is a new role in the DM Operations department. The Lead Trial Data Manager will work across multiple clinical trials and be responsible for developing and maintaining data standards in our different systems - all the way from (e)CRF to SDTM. The Lead TDM will review protocols and Trial Outlines and guide the TDMs in setting-up trials, especially in regards to data standards. This also means you will be consulted for advise whenever there is a change request to our (e)CRF. The Lead TDM will be heavily involved in the process around submitting our data to the approving authorities.You will work closely with other Data Management colleagues as well as other stakeholders e.g. Statisticians and Trial Managers. It is expected that you can handle all data management trial related documentation as well as have a strong understanding of how the data is used by our statistical programmers and statisticians. It is also expected that you are a strong communicator with good project management skills, able to deliver in high quality and on time.Development of methods and processes, as well as knowledge sharing is continuously on-going in Novo Nordisk, especially based on the initiative of the employees. We strive to ensure the maintenance of Data Management as a good and challenging place to work, thus we expect that that understanding, utilizing and communicating best practice methodologies will be a part of your daily work tasks. In exchange we of course offer great opportunities for on-going training to ensure the continued competency development of our employees. Qualifications You have a B.Sc. or M.SC within IT, natural sciences or other relevant degree and extensive knowledge and experience from the Pharma industry and GCP knowledge. It is a prerequisite that you have worked several years with clinical data management. The job requires a strong knowledge of Oracle Clinical, InForm and relational databases. Furthermore strong project planning and project management skills are necessary. You have excellent overview, presentation and coordination skills. You are capable of working independently, take on responsibility and show initiative. 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. Furthermore, good English skills, strong cooperation and analytical skills are a necessity. At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possib

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