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, 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. The role entails a wide range of tasks from creating clinical evaluation plans to managing the execution of planned clinical trials and activities. 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:
- Mapping the clinical data need for existing and future products
- Creating clinical evaluation plans
- Design clinical trials within the area of BAHS implants and surgery
- Ensure documentation for clinical trials are complete and up-to-date
- Operational tasks within clinical trial management
- 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.
Experience with clinical trials and clinical evaluations
The ideal candidate will have the following qualifications:
- Relevant academic background (typically a Master’s degree in biomedicine, biomaterials, engineering or similar)
- Experience with clinical evaluations of medical devices
- 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
- 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
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.
Even if you don’t have all competences and experiences above, we would like to hear from you.
Our offer to you
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.
Application and contact
To learn more about the job, please contact Director, Clinical Affairs, Surgical Systems, Sofia Jonhede ([email protected]: phone: +46763286731). Please send your application and CV .
Application can be provided in English, Swedish or Danish. Read more about Oticon Medical on www.oticonmedical.com
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.
