Smørum

Clinical Research Study Coordinator

Fakta

Lokation:
Smørum
Ansøgningsfrist:
20/04/2019
Afdeling:
Clinical
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Clinical Research Study Coordinator

1 year maternity cover starting May 2019, with possibility of extension

 

We offer you a chance to join Oticon Medical for an exciting opportunity within the Danish organization.

It will be your responsibility to drive our clinical studies and research projects for Cochlear implants (CI) with partner clinics in Denmark in particular - and the Nordics in general. You are to drive clinical research study initiatives that support our business goals as well as demonstrate our commitment to take CI outcomes to a new level. You will help us build clinical documentation for our current CI solutions as well new concepts and developments. Furthermore, you will be part of bringing completely new products to the market.

 

You proactively define and setup clinical research with partners supporting our business goals

As Clinical Research Study Coordinator, your role will be to proactively define research and post-market studies and align our business goals short and long term. Short-term means generating clinical data by documenting our current or upcoming products in the field. On a long-term basis means enabling clinical evidence of novel concepts and developments that we might include in future solutions. You will have a close connection to clinical and academic partners in Denmark, Nordic countries with a relay to our global CI Clinical affairs team in Nice.

Furthermore, you will drive and coordinate a wide portfolio of studies ranging from audiology to surgically focused studies.

 

The position is based in Oticon Medical in Smoerum, Denmark, where you will be part of the Oticon Medical global Research & Technology development team and the Danish sales team. You will be supported by our global CI Clinical affairs team in Nice on study design, protocol writing and good practice for clinical studies and you will ensure that study plans and results are continuously coordinated with the global CI Clinical affairs team.

 

Summed up, you will be responsible for the following tasks:

  • Develop clinical research studies in collaboration with partners in the Nordics
  • Ensure Nordic clinical research studies are aligned to business goals and needs
  • Write study protocols, case report forms and facilitate approvals at relevant authorities
  • Ensure documentation for clinical trials are complete and up-to-date
  • Ensure or carry out relevant monitoring activities
  • Analyze data and conduct statistical analysis
  • Support our marketing function in communication of results, e.g. in the form of whitepapers
  • Support partners in scientific publication of results
  • Present study results at relevant fairs, conferences and Oticon Medical symposia

 

You can expect 20-30 days of business travel per year primarily in the Nordics and to the Oticon Medical office in Nice.

 

 

An expert in Cochlear Implants with a drive for clinical studies

We would hope you bring in the following qualifications:

 

  • PhD in the hearing science domain, preferably with a specialization in Cochlear Implants (audiological or surgical topics)
  • Experience with designing and preparing clinical research & post-market studies of medical devices
  • Experience with interfacing to relevant authorities for study approval in Denmark is a plus
  • Experience in monitoring and reporting on a clinical study
  • Working knowledge of relevant regulations for clinical research & studies
  • Good communication skills, and speak and write English proficiently (corporate language is English)
  • Danish speaking or willingness to learn Danish to be able to communicate with Danish CI patients is a plus

 

Moreover, we hope to see the following skills in your CV:

  • Statistical knowledge and skilled at statistical analysis
  • Experiences from negotiating contracts on clinical research & post-market studies

 

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. You like to get things done. 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.

 

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.

 

We believe in the good life

Oticon Medical offers many challenges in an international organization full of energy and expertise. The right candidate will learn very much in a short time span, since you will have the opportunity to work with all aspects of clinical studies. Personal and professional development is the foundation for the growth of our business.

We create solutions that allow people to live their lives to the fullest. We also recognize in order to bring energy and inspiration to work, you need to re-energize and spend time with family, friends and hobbies in a healthy work life balance.

 

Application and contact

To learn more about the job, please contact Senior Director, Research & Technology Development, Søren Riis (srka@oticonmedical.com) phone: +45 5117 6671. Please send your application and CV online only and no later than April 20th 2019.

 

Oticon Medical is part of Group Demant with more than 14.000 employees across the world and revenues of over DKK 14 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.