Description
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Study Manager Cardiology (m/f)
Referenz: -en
Beginn: 01/12
Dauer: 12 MM++
Ort: in Bavaria
Branche: Herstellung von medizintechnischen Apparaten und Materialien a. n. g.
Ihre Aufgaben:
- Planning of the study specific content and budget within the development/project team and controlling the related agreed upon budgets during the study
- Planning, procurement, preparation and delivery of materials necessary for carrying out the study
- Ensure compliance to all relevant SOPs and guidance documents in the course of all studies e.g. studies to gain CE labeling or FDA approval and compliance to all safety and quality management regulations
- Develop study design in coordination with external experts and the development/project team
- Site assessment and site selection in collaboration with Global Monitoring
- Prepare study protocol in a coordinated manner with internal and external experts
- Organizational set up of the study, supervision of coworkers in matrix organization, continuous analysis and validation of the incoming data, assessment of the results and immediate communication especially in case of unexpected observations
- Preparation of a study report including recommendations and corrective actions
- Transition of study results into scientific publications together with external and internal experts
- Initiate and ensure contacts to international experts and customer groups to use the external know-how for the development of new products and to guarantee acceptance of new products
- Continuous follow up on market developments and competitor products
Ihre Qualifikation
- Natural science or medical degree (MD or PhD)
- Experience in the biochemical, immunological, chemical or biophysical area
- Confident use of English in negotiation, multi-project-management, knowledge in biometry, electronic data processing and statistics, affable conduct and confident appearance
Skills:
- Clinical Project Management