Senior Clinical Research Specialist

Seuss+

Growing Medical Device Company based in Denmark is seeking a Senior Clinical Research Specialist to join their expanding team

Senior Clinical Research Specialist
  
Do you have a passion for working with clinical documentation and clinical investigations as part of innovative Medical Device projects? Are you able to take responsibility for the strategic direction of how you work to document Medical Devices? And do you want to join a successful company in rapid growth? Then we have an exciting job opportunity that may be your next career move…
  
Our client, based in Denmark, develops, produces and sells Medical Devices, which enable doctors and nurses to save lives and improve patient care.
  
We are offering a challenging position where you will be an important player in the Clinical Research & Biosafety team placed under Global Innovation. You will participate in securing their ongoing dedication to quality products. You will be part of an effective innovation culture with a tradition for fast completion of projects, which means that there is a visible link between your results and the company’s growth.
  
Job Requirements   
As Senior Clinical Research Specialist, you will join a highly skilled and professional team. You will help the company set the right scientific level when implementing international clinical Medical Device legislation and regulation. This means that you will take responsibility to set the right documentation level and at the same time act as sparring partner in product development projects and product improvement projects. You will balance your clinical scientific view with a hands-on approach in the projects as you plan and execute continuous clinical evaluation of our client’s products. You will define clear and operational targets within the clinical area. As a Clinical Specialist, one of your focus areas will be to write and review clinical Medical Device documentation. You will also act as an expert in regulations and guidelines related to the clinical area. Together with the rest of the team, you will be a “go-to" person for the project members when setting the bar for clinical documentation.
  
Areas of
responsibility:

  • Independently prepare clinical documentation to support product approval
  • Plan, coordinate, execute and report clinical investigations and pre-clinical activities
  • Lead the planning and writing of publications and medical marketing documentation, to support the company’s products
  • Provide clinical input to safety assessments and vigilance reporting
  • Actively stay updated in relevant clinical areas, medical literature and relevant regulatory requirements
  • Build international network of specialists and KOLs in relation to development projects
  • Support/guide other clinical staff in medical writing tasks, including review of documents
  • Be an expert in literature searches and medical writing incl. relevant guidelines
  • Provide knowledge sharing with colleagues
Personal Requirements
  
To succeed in this position, you will:
Hold min. 5 years of experience within the clinical Medical Device area
Hold an academic degree in the clinical industry or a nursing degree
Need to be well versed in EU and FDA regulations and guidelines related to the clinical area
Have experience in working as the clinical competence in Medical Device development projects.
  
As a person, you act as a champion for change and take the ownership for following through on changes. You are an efficient communicator and you are a good networker as this will help you to succeed in the job. Additionally, you make accurate judgements and decisions and you drive continuous improvement.
  
Finally, you need to have excellent command of the English language, as this will be your main working language, - verbally and in writing.