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Clinical Trial Manager for Oticon Medical
We offer you a chance to join Oticon Medical for an exciting opportunity within the Clinical Affairs team. You will help us build clinical documentation for our current Bone Anchored Hearing System (BAHS) and new developments. You can also look forward to being part of bringing completely new products to the market – and work with the clinical trials that allows that.
Based at Oticon Medical AB in Askim, Sweden you will become part of an interdisciplinary environment at Oticon Medical’s offices in Gothenburg and Copenhagen, Denmark.
You plan and conduct clinical trial activities:
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. You work closely together with our R&D, QA/RA and marketing groups. You will 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 varying, stretching from strategic directions to the hands-on execution of clinical trials.
As we are a multi-sided company, we work across countries. You can expect 20-40 days of business travel per year.
Want to see it from our side? Then we these might be your entry if…
You have a:
? 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, and have an eye for detail but never lose the overview. You get things done.
OBS! Even if you don’t have all competences and experiences above, we would still like to hear from you. There will be possibilities for the less experienced candidate to grow with the tasks.
Our offer to you:
Oticon Medical offers many challenges in an international organization full of energy and expertise. We offer flexible working conditions and you will be part of an environment based on trust and openness.
Want to join – look below how to!
To learn more about the job, please contact Director, Clinical Affairs, Surgical Systems, Sofia Jonhede (firstname.lastname@example.org: phone: +46763286731), or questions related to the recruitment process, Ditte Mi Petræus on +45 53813547. Please send your application and CV via www.oticon.com. Application can be provided in English, Swedish or Danish. Read more about Oticon Medical on www.oticonmedical.com
Oticon Medical is part of William Demant Holding with more than 14.000 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.
VillkorVaraktighet och arbetstid:
6 månader eller längre, Heltid
OTICON MEDICAL ABHemsida:https://www.oticonmedical.com/