stillingsbetegnelse: Clinical Data Surveillance Specialist

jobbeskrivelse:
- Research & Development - 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. Are you passionate about clinical trials and data interpretation, and do you want to drive the capturing of unusual data patterns? We are looking to employ two Clinical Data Surveillance Specialists to establish and operate the Clinical Data Surveillance function in Global Development. 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 positions are based in the Medical Anchor within Trial Execution. We are a team of dedicated employees of diverse background with an important role in the development of new drugs at Novo Nordisk as responsible for process optimisation and competency building within the medical and trial management area globally. We also contribute to the results of the projects by ensuring sharing of best practice and knowledge across projects and regions. The job As Clinical Data Surveillance Specialist, you are responsible for establishing and operating the centralised Clinical Data Surveillance function in Global Development. The Clinical Data Surveillance function is responsible for capturing of clinical data patterns which could indicate irregularities, non-compliance with protocol specifications, or fraud not otherwise captured. You will use the relevant IT tools, interpret the data and communicate the findings to the study groups, project teams, and management. In this way you will continuously contribute to the data quality of our clinical trials and improve the level of compliance with regulatory requirements. You can look forward to an exciting job collaborating with a wide range of stakeholders across Novo Nordisk. The job is based in Søborg, Denmark. You will report to the Director of Medical Anchor and take active part in the team, contributing to the maintenance and development of Medical Anchor as being an attractive and challenging place to work. Qualifications You hold a relevant university degree in life science or engineering (e.g. MSc, MD, DVM) or equivalent combined with 3-5 years of experience with interpretation of clinical trial data. You have thorough understanding of clinical drug development and the related data flow. You are experienced in Good Clinical Practise. You have knowledge of basic statistical methods, preferably experience from reporting or publishing clinical or scientific data. You have flair for IT at an advanced user level. You possess proven strong analytical skills, and you excel in tutoring and data presentation. You are well organised, strong communicator, and have solid problem-solving capabilities. You can keep your spirits high even when under pressure, and you can collaborate at any organisational level. You are change-prepared and have a proactive mind-set. Finally, you are fluent in written and spoken English. At Novo Nordisk you will work with specialists from around the world. Our ambitious teams work toward developing the next generation of care. As a growing organisation, we offer unique possibilities for personal and professional development, as well as a chance to work alongside the best in the field. Contact For further information, please call Thue Johansen on +45 3079 9664. Deadline 4 December 2014.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Andet ingeniørarbejde (undtagen elektroteknologi)

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark