Clinical Trial Manager to Cochlear in Gothenburg

Cochlear Bone Anchored Solutions AB is committed to hearing and facial rehabilitation.We are a rapidly expanding medical device company focusing on bone anchored solutions based around the principle of osseointegration.On our website you can find out more about how our product systems Baha® and VistafixT is improving the quality of life for people all over the world.Entific Medical Systems AB was created in 1999 as a spin off of the Swedish oral implant group, Nobel Biocare.In March 2005 Entific was acquired by Cochlear Ltd of Australia, the world leader in cochlear implants and became Cochlear Bone Anchored Solutions AB.Since its inception, Cochlear has shown healthy growth especially in the hearing rehabilitation market.Dynamic product development, well adapted products, a committed team who understand the medical environment and high patient satisfaction mean this success looks set to continue.New indications in hearing rehabilitation will further broaden in future.This has contributed to a highly enlarged sales organisation and will further strengthen the organisation.Read more on website: www.cochlear.com The turnover for the total Cochlear group is 2,4 Billion SEK and the average number of employees are 1100.Cochlear needs to further strengthen the Research & Application team The main task as Clinical Research Manager at Cochlear BAS will be to plan and coordinate clinical trials in the medical device environment.The person will work close together with running projects and also the rest of Cochlear's Clinical Trial organization (Basel, Sydney).Responsibilities and Job description .Practical planning and coordination of clinical trials . In alignment of Cochlear Ltd be responsible for the development of clinical trials routines within Cochlear BAS . Responsibility for follow-up of clinical trials . Responsible of writing Investigator brochure, CIP (Clinical Investigation Plan), CRF (Case Report Form), and master informed consent .Monitor clinical studies according to good clinical practice .Writing and Co-writing of clinical reports . Close collaboration and alignment with Cochlear Clinical Trial department in Basel.For this new position within Cochlear BAS we are looking for someone that already has worked some years as Clinical Research Manager or has similar experience from clinical trials.Knowledge of the medical device industry and applicable standards such as ISO 14155 and others is of course desirable.Experience from dealing with the Swedish and UK Authorities is another strong wish.We think that the person we are looking for has a relevant scientific background such as nurse, pharmacist or biologist.Previous experience of working in a smaller organization is a plus as the person needs to be able to work independently, take big responsibility and have a driven character.Other key factors we are looking for are excellent communication skills and fluent in English. We cooperate with Proffice Life Science in this recruitment process.Apply before 15th of January 2007.