Clinical Trial Manager for Oticon Medical
Oticon Medical AB / Apotekarjobb / Göteborg
2018-05-15
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➡️ Klicka här för den senare publicerade platsannonsen "Clinical Trial Manager for Oticon Medical" (publicerad 2019-02-12) ⬅️
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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 clinical trial activities with focus on BAHS implants and surgical aspects to help us ensure that our clinical documentation meets relevant requirements and standards. You will 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 documentation and 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
• 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 Master's degree in biomedicine, biomaterials, engineering 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
• Experience with clinical evaluations of medical devices
• Good working knowledge of relevant regulations, e.g. ISO14155, relevant MEDDEV's, MDD/MDR
• Experience in documenting clinical trials as well as writing publications
• Good communication skills, and speak and write English proficiently
Moreover, we hope to see the following skills in your CV:
• Previous work in an Clinical Affairs setting
• Knowledge of bone anchored or other hearing devices
• Statistical knowledge and skilled at statistical analysis
• Experiences from negotiating contracts on clinical studies
• Research experience in a relevant academic field
We are looking for a team player who finds it inspiring to discuss challenges with colleagues, but who can also initiate and conduct tasks by him/herself. You have a scientific approach, and you also acknowledge the business point of view. You are pragmatic, results oriented and get things done. You have an eye for the detail as well as an overview.
About Oticon Medical
Oticon Medical is part of William Demant Holding with more than 13.000 employees across the world and revenues of over DKK 13 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 lifechanging implantable hearing systems.
Publiceringsdatum2018-05-15Så ansöker duSista dag att ansöka är 2018-06-14
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 4144009
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