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Job titleSenior Clinical Research Specialist
Job typeMeditech
Salary DKK
LocationEurope
Bonus Package
Job description

A market-leading developer of single use instruments is currently looking for a Senior Clinical Research Specialist to join their team in Denmark to be involved in new product development projects. If you have experience with clinical documentation and are passionate about bringing products to market, this could be the perfect role for you. 
 

The company 

Our client has over 80 years of experience and a world-leading reputation in the single-use instruments space, with a focus on high-quality, cost-effective products that improve patient safety. They are rapidly growing and have strong projections for the future and are constantly making investments in new product development. 

As one of the largest providers of single use medical devices, they are supported by a strong research and development arm that is constantly innovating and collaborating with healthcare professionals on new products. Healthcare providers and patients around the world are positively impacted by their products! 
 

The role 

As Senior Clinical Research Specialist you will play an important role in the Clinical Research team and will be responsible for the strategic direction that brings new products to market and supports market penetration. You’ll be involved heavily in clinical documentation and defining the clinical information required for this, as well as executing clinical evaluation on a wide product portfolio. 

Our client aims to get their products to market quickly, without this impacting on quality and you will play a significant role in this by preparing the clinical documentation to support product approval.  

In this role you’ll join a team of likeminded individuals who are highly skilled. If you’re confident with handling clinical projects and are looking for a professional challenge, this could be the perfect next step in your career. 

 

Responsibilities include: 

  • Preparing and advising on the contents of clinical documentation to support product approval 

  • Planning and reporting pre-clinical and clinical investigations 

  • Staying up to date in relevant clinical areas, including new regulations 

  • Helping the team to understand levels of scientific and clinical documentation for new products 

  • Planning and executing clinical evaluation of products 

  • Support and guide other clinical staff in writing and documentation  

  • Reviewing clinical documents 

  • Enabling the demonstration of the value of clinical products in the market 

  • Helping to bring new products to market quickly and effectively, in line with clinical and quality regulations 

 

 

The requirements 

You will live in the Greater Copenhagen area or within a commutable distance to it. You’ll ideally be experienced in the clinical medical devices space, as well as… 

 

  • Degree educated in a relevant clinical discipline 

  • Knowledgeable in EU and FDA regulations and guidelines 

  • Experience working in clinical competence for medical device development projects 

  • Able to take ownership of projects and work autonomously 

  • Experience working collaboratively on projects  

  • Strong written and verbal communication skills 

  • Excellent English language skills (written and verbal) 

  • Experience driving continuous improvement 

  • Strong networking skills 

  • Able to navigate a clinical development environment 

  • A strategic thinker 

  • Experience in clinical research 

 

Important information 

FMC contact for the role: Charlotte Ashton (charlotte.ashton@fmctalent.com) 

Reference number: 8922 

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Updated on 2017-08-07T17:04:38+00:00, by Matthew Graham.