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Clinical Trial Assistant

Location: 

Humlebæk, DK

Job Family:  Research & Development
Country/Region:  Denmark

 

Would you like to be part of the planning and execution of clinical studies for a medical device market leader? And do you want to work for a company that makes a real difference to people with intimate health care needs?

 

Become part of key team 
At our head quarter in Humlebæk, you will join 16 colleagues in the Clinical Operations team in Medical Affairs. We are executing clinical investigations within our Chronic Care and Wound Care portfolios worldwide. Our clinical agenda is growing, we are developing more clinically differentiated products, and with this the need for clinical evidence is critical. 

 

“The data we generate is crucial for Coloplast’s strategic goals, giving us a vital role in the future success of our organisation,” says Director Clinical Operations Pernille Trøjgaard. 

 

Ensure high quality in clinical investigations
As a Clinical Trial Assistant, you will administer, maintain and coordinate the logistic aspects of our clinical studies and be responsible for the management of study documentation in our larger studies. It is a newly established position in our department, so you will have the opportunity to influence the role and responsibilities.

 

To facilitate studies, you will collaborate and build great working relationships with colleagues in Medical Affairs (clinical managers, data managers, statisticians and scientific managers) as well as external partners like CROs and health care professionals and hospitals. Ultimately, your work will help providing patients, doctors and nurses with the best possible health care and treatment solutions.

 

More specifically, you will:

  • Support the clinical managers preparing submission packages to authorities and/or ethics committees and assist in quality control of submission packages
  • Support clinical managers in planning and management of our clinical trials from preparation until closure and archiving
  • Be responsible for setting up and maintaining the Trial Master Files and Investigator Site Files
  • Plan, maintain and keep track of study supplies and study devices
  • Secure adherence to ISO 14155, current regulatory requirements and internal SOPs
  • Support the development and maintenance of procedures/instructions/SOPs for Clinical Operations
  • General administrative support to Clinical Operations (e.g arrange meetings, handling of supplier information/contracts etc.)

 

Experience with clinical trials and quality minded

  • You have several years of experience in management and oversight of trial documentation and study supplies
  • You possess knowledge of regulations, guidelines and directives within clinical studies    
  • You have solid IT skills
  • You are self-driven, proactive and detail-oriented
  • You are fluent in spoken and written English

 

It is essential that you are service-minded, have a structured approach to your work and the ability to keep momentum going and work independently. Your good interpersonal skills help you to build relationships and collaborate effortlessly with internal and external partners. 

 

Interested?  
If you would like to know more about the position, please call Director of Clinical Operations Pernille Trøjgaard at +45 4911 2640 or Head of Clinical Trial Management Marie Louise Mohr at +45 49113506. 
We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate has been found. 
 

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

 

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

 

Visit us on Coloplast.com.

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