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Clinical Trial Assistant (Office Based)

Copenhagen, Denmark

Qmed Consulting A/S is a full-service medical device Contract Research Organisation (CRO), also providing strategic consulting services. We specialise within medical devices, in the following departments:
•    Clinical Affairs
•    Regulatory Affairs
•    Quality Management
•    Commercial Healthcare
•    
The driving force behind Qmed Consulting is our commitment to paving the way for new medical devices and new ideas to allow them entry to the market. Find out more on www.qmed-consulting.com. We value an open, trust-based and creative working environment, great team spirit and a high quality mind-set. Our working environment is characterised by interesting and demanding assignments.  We offer a career in clinical trials, where you will be challenged every day in a friendly and exciting work environment.
This is an office based position in Central Copenhagen.  You will need to be proficient in both written and spoken English and Danish.
 

Your main responsibilities will include, but are not limited to:


The Clinical Trial Assistant plays a key role within Qmed Consulting to  administer, maintain and coordinate the logistical aspects of clinical trials, while ensuring compliance with ISO standards, Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs). The CTA also acts as a pivotal point of contact and support for the clinical trial team.

The CTA will be involved in most activities for the preparation of conducting and completing a Clinical Trial. You will be responsible for setting-up and maintaining the Trial Master Files (TMF), the Investigator Site File (ISF), and/or other electronic filing systems. You will prepare essential clinical trial documentation, distribute, track and file documents. You will ensure that clinical trial databases/tracking tools are set-up and maintained throughout the trial. You will be involved in preparing and maintaining study documents, such as, Protocols, Investigator’s Brochures, functional plans, and case report forms. In collaboration with the CRAs, you will manage and maintain trial supplies e.g.; medical devices, patient Information sheets, patient diaries, lab kits and medical equipment for sites. You will arrange and participate in the organisation of Investigator Meetings and Study Team Meetings, including the generation and distribution of minutes. You will assist with the Ethics / Regulatory Submissions and keep track of submissions and approvals for the study.

Other possible tasks may include assisting with CRF Design, database user testing, arranging translation of patient documents, and assisting Clinical Research Associates on monitoring visits.

What we look for in a candidate:
Successful candidates are likely to be experienced in administrative support in a busy environment.
You have a university degree or equivalent in health sciences, nursing, pharmacy or similar, and are experienced in the planning and execution of clinical trials. 

 
  • You have excellent organisational and prioritisation skills and good attention to detail.
  • You have excellent communication skills and you aim to reach deadlines, are proactive, flexible, and able to multi-task.  
  • You have solid IT skills and work in an organized manner with an attention to details.
  • It is essential that you can work independently, but also be an active contributor within a team.
  • You have the ability and willingness to adjust quickly to new situations in a continuously developing environment.
  • You understand clinical trial processes and needs, including knowledge of ICH GCP and/or ISO 14155. 
 
Sounds like you?
If you have any questions regarding the position, you are welcome to contact us at +45 56 64 1010 or sjo@qmed-consulting.com.
Start date is as soon as possible, but we will wait for the right candidate.
 
We look forward to hearing from you.


 
 

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