Clinical Trial Manager
Are you ready to make a difference for people with a severe hearing disability? Do you want to make a difference for users and patients with Bone Anchored Hearing Systems (BAHS)? Do you want to play an instrumental part in bringing new products to the market? Then we have an exciting opportunity for you as Clinical Trial Manager at Oticon Medical AB in Askim, Sweden.
You plan and conduct clinical trial activities
As Clinical Trial Manager, you have a central role in supporting BAHS implants and surgical techniques with clinical evidence. This goes with operational responsibilities for clinical study planning, study execution, and reporting.
You work closely together with our R&D, QA/RA, and marketing groups. For successful outcomes, you also need to build relationship with external clinicians and researchers in the field.
You will be responsible for the following tasks:
- Planning and execution of clinical trials for BAHS implants and surgery
- Drive submissions and correspondence with ethical committee and competent authorities
- Complete documentation for clinical trials according to regulations
- Secure high data quality by relevant monitoring activities
- Build and maintain a study database
- Ensure data export and statistical analyzes
- Contribute to further improvements in internal procedures for clinical trials
You can expect 15-30 days of business travel per year with variation depending on project and phase.
- Relevant academic background (typically a Master’s degree in biomedicine, biomaterials, engineering or similar)
- Experience with designing and preparing documentation for clinical trials is considered beneficial, ideally having worked in a medical device company or CRO
- Experience with both pre- and post-market clinical trials is an advantage
- Experience in monitoring
- Good working knowledge of relevant regulations, e.g. ISO14155, Good Clinical Practice
- Good communication skills, English proficiently
Moreover, we hope to see the following skills in your CV:
- Previous work in an R&D setting, where products and ideas are constantly evolving
- Statistical knowledge and skilled at statistical analysis
- Experiences from negotiating contracts on clinical studies
- Research experience in a relevant academic field
To be successful in your role you are a team player who finds it inspiring to discuss challenges with colleagues, but you can also initiate and conduct tasks by yourself. You have a scientific approach, and you also acknowledge the business point of view. You are pragmatic, result-oriented, and get things done. You have an eye for the detail as well as an overview.
Why joining Oticon Medical!
Joining us, you will get the opportunity to work with something that matters! What we do makes an enormous difference for people, and we constantly strive to improve ourselves. This has led us to a point where we have a portfolio of top-of-the-line products, some of the best employees in the field and consequently a strong financial growth. Being part of Demant Group, a global leader in hearing healthcare with more than 16500 employees in 130 countries, we have the power to make a difference globally and provide you with great personal development and career opportunities.
This recruitment is handled by our recruitment partner, Moveup Consulting AB. To apply, please send your CV and a cover letter to firstname.lastname@example.org
If you have questions regarding Oticon Medical or this open position, please contact Tom at +46 (0)733 87 27 22. We are screening applications continuously. Please send your CV and cover letter no later than 25th of October.
By submitting your application, you also consent to us storing your personal data, including CV & cover letter and that we have the right to share this information with third parties (our client). You can revoke the consent whenever you want.
Oticon Medical is a global company in implantable hearing solutions, dedicated to bringing the power of sound to people at every stage of life. As part of the Demant group, a global leader in hearing healthcare with more than 16,500 people in over 30 countries and users benefitting from our products and solutions in more than 130 countries, we have access to one of the world’s strongest research and development teams, the latest technological advances and insights into hearing care.
Our competencies span more than a century of innovations in sound processing and decades of pioneering experience in hearing implant technology. We work collaboratively with patients, physicians and hearing care professionals to ensure that every solution we create is designed with users’ needs in mind. We have a strong passion to provide innovative solutions and support that
enhance quality of life and help people live full lives – now and in the future.
Because we know how much sound matters.