stillingsbetegnelse: International Trial Manager in Global Development

jobbeskrivelse:
- Research & Development - Denmark - Søborg Do you have a passion for improving the lives for patients suffering from rare, but potentially debilitating and life-threatening diseases? Do you thrive on working with people in a dynamic and global environment within the Haemophilia area? Then we may have the right job for you. We currently have two vacancies in Haemophilia Clinical Operation 4 and are looking for two new colleagues with passion for clinical trial management to join us. A permanent International Trial Manager position as well as a temporary International Trial Manager vacancy for 10 month covering a maternity leave. 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 In Clinical Operations Haemophilia, we are approximately 72 highly skilled and ambitious employees. We are responsible for the planning, execution and finalisation of clinical trial activities in phase 1-4 within our Haemophilia portfolio. In the Clinical Operation 4 department we are responsible for the life cycle management of NovoSeven®, NovoEight® and NovoThirteen®. We create additional value to the launched brands by conducting clinical trials, PASS studies as well as non-interventional studies. You will be part of a team of one Clinical Project Manager, 12 International Trial Managers and 5 Clinical Trial Administrators all working on the life cycle management for NovoSeven®, NovoEight® and NovoThirteen®. We collaborate with our Novo Nordisk affiliates worldwide, internal stakeholders from various functions as well as external vendors. We value an open, trust-based and creative working environment, great team spirit and a high quality mind-set. Our working environment is characterised by interesting and demanding assignments and continuous professional development opportunities. The position As International Trial Manager you will be responsible for timely planning, execution and finalisation of clinical trials using your operational and therapeutic experience. You will chair the International Study Group and ensure coordination of trial management activities in a proactive way through clear communication and teamwork skills. Organising and executing team meetings as well as planning, preparing and presenting at global investigator and monitor meetings are also part of your responsibility. You have a structured and analytical approach as well as a high quality mind-set when developing trial documents such as protocols, monitoring guidelines, recruitment and retention strategies, risk management plans, communication plans etc. You sense the importance of detail when setting up a trial and providing input to clinical IT systems. At the same time you are able to digest complex data output and evaluate the level of data quality during a trial. You are able to ensure progress of trial activities within given timelines and in accordance with the trial budget prepared by you. Qualifications You hold a university degree in Natural Science or equivalent with a minimum of 2 years’ experience in trial management as well as clinical trial methodology. You have solid project management/leadership skills and work in an independent manner. You must have the drive and focus to meet challenging deadlines and know how to prioritise between different tasks in a dynamic environment. You are a dedicated team player with a high degree of flexibility and cross-cultural awareness who inspires trust amongst colleagues and partners. Proficiency in written and spoken English is essential. Working

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