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Global Clinical Research Specialist - Ballaigues, Switzerland

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Global Clinical Research Specialist - Ballaigues, Switzerland

MISSION

As Global Clinical Research Specialist in our Clinical Research group, you will provide technical and scientific expertise to our Clinical Affairs, R&D, Quality, Sales, Marketing and Manufacturing departments for the development and commercialization of medical devices.

MAIN RESPONSIBLITIES

  • Create and update Clinical Evaluation dossiers for new medical devices and already marketed products in accordance with NF EN ISO 14155:2012, MEDDEV.2.7.1, MDD (93/42/EEC), MDR (2017/745), as well as Post Market surveillance data
  • Represent Clinical Research in project teams for new product development
  • Implement / manage research studies
  • Manage / implement pre- and post-market sponsored clinical studies (phase I- IV) as well as investigator-initiated studies, including communication with university groups, Key Opinion Leader Management, writing of Clinical Investigation Plan, IB, CRF, etc.
  • Create and update clinical documents for launched product support, including performing literature searches, data interpretation and creation of scientific communication documents
  • Perform biological safety assessments for new products in development and marketed products
  • Support in the creation and review of technical files
  • Support in the review of documentation (labelling) 

PROFILE

  • Masters or PhD in science, biological science, medicine, or equivalent
  • Minimum 3 years' relevant professional experience with medical devices in an international environment
  • Very good knowledge of ISO 13485, Guide MEDDEV. 2.7.1 4, good knowledge of ISO 10993-1, as well as European Regulatory rules (MDD) and US (21 CRF) concerning medical devices, FDA
  • Good knowledge of Clinical search best practices concerning medical devices and related statistics, ICH (Guideline for Clinical Trial)
  • Very good knowledge of MS Office + ERP (i.e. MS Project)
  • Excellent communication skills in French (B2/C1) and English (B2/C1); German is a plus
  • Strong skills in writing scientific and technical documentation
  • Good knowledge of scientific databases for documents research
  • Proactive, cooperative attitude
  • High analytical skills
  • Service- and customer-orientation
  • Ability to work autonomously
  • Very good organizational and planning skills

Ballaigues / Baden-Dättwil / Baden / Bern

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