stillingsbetegnelse: Risk Based Monitoring (RBM) Specialist

jobbeskrivelse:
- Biostatistics and Data Management - Denmark - Søborg Would you like to be part of implementing Risk Based Monitoring (RBM) in Novo Nordisk? We are establishing a new Centralised Monitoring Unit (CMU) who will drive the implementation of RBM and ensure compliance with the new regulatory requirements. 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 CMU unit will be anchored in Clinical Systems & Data Management (CS&DM) which today consists of approximately 130 highly skilled people based in Denmark, responsible for providing data management expertise and resources to clinical development projects and supporting our global clinical IT systems. We work closely with all other skill areas in Global Development, i.e. Trial Management, Clinical Pharmacology, Biostatistics, Medical & Science as well as with our Global Development Global Service Center (GD GSC) in India, and the global Clinical, Medical & Regulatory (CMR) organisation. The new unit will drive how Novo Nordisk will implement RBM, ensuring compliance with the new regulatory requirements as well as establish and maintain how to conduct medical monitoring and develop reports to support Risk Based Monitoring (RBM) for the global clinical trial portfolio. The Job We are looking for 2 Risk Based Monitoring (RBM) Specialists who will be part of driving the implementation of RBM. Together with your new specialist colleague, you will be responsible for the operational execution of RBM from an HQ perspective which to begin with includes driving the first pilot and roll out as well as adoption of new processes in the Global Development and CMR organisation. This includes training and on-boarding of staff in processes and execution. The RBM specialists will be collaborating closely with other functional areas in Global Development as well as with our colleagues in the CMR organisation and will be responsible for development and operational execution of RBM, including training and education of RBM to stakeholders across the global development organisation. Qualifications You have a master’s degree in natural sciences or similar and significant work experience from the pharmaceutical industry. You have a thorough end-to-end understanding of clinical development, leadership and project management experience with a proven track record in delivering results via teamwork in a cross-cultural setting. Experience with RBM will be an advantage. You must be fluent in English, have a proactive mindset and ability to work independently in a continuously developing environment. You possess proven strong analytical skills, and you excel in tutoring and data presentation. You are well organised, a 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. Novo Nordisk is a world leader in diabetes care. Our success is built on more than 90 years of innovation and commitment to patient-care. We combine world-class scientific, pharmaceutical, and clinical expertise with the highest ethical standards to continue to improve the quality of life of millions of patients across the world. Contact For further information, please contact Hanne Lang +45 3079 1989. Deadline 10 January 2016.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark