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Freelance Senior Clinical Trial Specialist (m/f/d) (EN)

[11511]
clinical trials, ISO 14155 + CE Zertifizierung

Job title: Freelance Senior Clinical Trial Specialist (m/f/d) Industry: Medizintechnik Skills: clinical trials,ISO 14155 + CE Zertifizierung Start of project: ASAP Duration of the project : 3 to 6 Months Project volume: 3 Month(s)  Location: Yverdon-les-Bains, Schweiz Tasks: ·Support the clinical affairs department in their activities. ·Leads studies within the clinical investigation area. ·Collection, organisation, and monitoring data according to best practises. ·Supervision, Monitoring and Execution/Submission of clinical trials procedures for medical devices in Germany, Austria. ·Design, monitoring, and submission of clinical studies. ·Development and implementation of CMP and all required documentations. ·Support in the annual update of clinical files related to MDR requirements. ·Collaborate with various internal and external stakeholders: RA, QA teams Qualifications: ·A university degree or equivalent Bachelor (FH) and/or Master in the field of Life Sciences or Biomedicine. ·At least 3 years’ experience in a similar role within the medical device sector: CRA, study coordinator. ·Sound understanding of regulatory requirements, ex ISO 14155. ·Fluency in English and German, French is an asset. ·Dynamic and flexible personality with excellent communication skills, both independently and as a team player.

Job title: Freelance Senior Clinical Trial Specialist (m/f/d)
Industry: Medizintechnik
Skills: clinical trials,ISO 14155 + CE Zertifizierung
Start of project: ASAP
Duration of the project : 3 to 6 Months
Project volume: 3 Month(s) 
Location: Yverdon-les-Bains, Schweiz

Tasks:

  • Support the clinical affairs department in their activities.
  • Leads studies within the clinical investigation area.
  • Collection, organisation, and monitoring data according to best practises.
  • Supervision, Monitoring and Execution/Submission of clinical trials procedures for medical devices in Germany, Austria.
  • Design, monitoring, and submission of clinical studies.
  • Development and implementation of CMP and all required documentations.
  • Support in the annual update of clinical files related to MDR requirements.
  • Collaborate with various internal and external stakeholders: RA, QA teams

Qualifications:

  • A university degree or equivalent Bachelor (FH) and/or Master in the field of Life Sciences or Biomedicine.
  • At least 3 years’ experience in a similar role within the medical device sector: CRA, study coordinator.
  • Sound understanding of regulatory requirements, ex ISO 14155.
  • Fluency in English and German, French is an asset.
  • Dynamic and flexible personality with excellent communication skills, both independently and as a team player.

map Vaud, Schweiz date_range ASAP update Freelance

Leïla Fehr

phone
+41 44 274 39 00
email
l.fehr@aristo-group.ch
Direct contact

Leïla Fehr

Recruitment Consultant
mail l.fehr@aristo-group.ch
phone +41 44 274 39 00

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