Sr. Clinical Trial Manager for Oticon Medical
Oticon Medical AB / Apotekarjobb / Göteborg
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hela Sverige Visa alla jobb hos Oticon Medical AB i Göteborg In your position as a Clinical Trial Manager, you play a key role with responsibility for planning and conducting external clinical trial activities with focus on BAHS implants and surgical aspects. You work closely together with our R&D, QA/RA and marketing groups. You also take part in building relationship with and connecting to researchers in the field.
Moreover, you will be involved in further improvements of the internal processes and procedures for clinical trials.
Summed up, you will be responsible for the following tasks:
• Design clinical trials within the area of BAHS implants and surgery
• Write study protocols and case report forms
• Write documentation for study approval by ethical committee and competent authorities
• Collaborate with CROs
• Ensure documentation for clinical trials are complete and up-to-date
• Ensure or carry out relevant monitoring activities
• Perform data management tasks
• Analyze data and conduct statistical analyzes
• Take part in developing our procedures for clinical trials and related activities
Besides the above mentioned, we give you the opportunity to further develop in our company as our product range and Oticon Medical grows. Your profile will help deciding the exact tasks you will work with, but the job will be extremely varying, stretching from strategic directions to the hands-on execution of clinical trials.
You can expect 20-40 days of business travel per year.
The ideal candidate will have the following qualifications:
• Relevant academic background (typically a degree in biomedicine, biomaterials, engineering, nursing or similar)
• Experience with designing and preparing documentation for clinical trials of medical devices, ideally having worked in a medical device company or CRO
• Experience with both pre- and post-market clinical trials
• Experience in monitoring
• Good working knowledge of relevant regulations, e.g. ISO14155
• Good communication skills, and speak and write English proficiently
Moreover, we hope to see the following skills in your CV:
• Knowledge of bone anchored or other hearing devices
• Statistical knowledge and skilled at statistical analysis
• Experiences from negotiating contracts on clinical studies
• Experience in writing publications
• Research experience in a relevant academic field
We believe that the best results come from a fruitful team effort, and it is important that you consider yourself as a team player who finds it inspiring to discuss challenges with colleagues, but who can also initiate and conduct tasks independently. We have an informal and creative atmosphere where mutual respect is pivotal, and we strive for the common goal.
You have a scientific approach, and you also acknowledge the business point of view. You are pragmatic, have an eye for detail but never lose the overview. You get things done.
Even if you don't have all competences and experiences above, we would like to hear from you. There will be possibilities for the less experienced candidate to grow with the tasks.
Oticon Medical offers many challenges in an international organization full of energy and expertise. You will be part of an environment based on trust and openness. We offer flexible working conditions. We are a fast-growing company, and there may be chances for a permanent position eventually.
Oticon Medical is part of William Demant Holding with more than 11.000 employees across the world and revenues of over DKK 11 billion. Oticon Medical is a market leading manufacturer of bone anchored and cochlear implant hearing systems for children and adults. At Oticon Medical we combine more than a century of experience in audiology and sound processing from Oticon with decades of pioneering experience in hearing implant technology. Our connection to Oticon gives us unique access to knowledge, resources and technology that we use for developing innovative and life changing implantable hearing systems.
Publiceringsdatum2018-10-15Så ansöker duSista dag att ansöka är 2018-10-31
Klicka på denna länk för att göra din ansökanKontaktSofia Jonhede
sojo@oticonmedical.comFöretagOTICON MEDICAL AB
AdressOTICON MEDICAL AB
Datavägen 37
43632 ASKIM
KontorsadressDatavägen 37
Jobbnummer 4401367
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