Medical Device Specialist

Vor 6 Tagen


Hannover, Niedersachsen, Deutschland Edwards Lifesciences Vollzeit
Job Summary

We are seeking a highly skilled Clinical Research Associate to join our team at Edwards Lifesciences in Germany. As a key member of our clinical research team, you will be responsible for ensuring the overall integrity of study implementation and adherence to study protocol at assigned clinical sites.

Key Responsibilities:
  • Study Organization and Supervision: Assist and conduct Clinical Monitoring activities, serve as key contact to assigned clinical sites throughout the study process, and be accountable for achieving and reporting on agreed clinical milestones.
  • Site Support and Training: Provide site and Edwards personnel training, including preparation and maintenance of study documents, completion of forms, and understanding of examinations and assessments required.
  • Adverse Event Processing: Document procedural case observations for insights in investigating post-procedural events, data review, safety reporting, and complaint handling.
  • Process Improvement and Audit Readiness: Identify and support process improvement opportunities and implementation, and ensure audit readiness for internal, external, and site audits.
Requirements:
  • Bachelor's Degree in a related field, with 3 years of experience in medical device and/or clinical experience.
  • Good computer skills in MS Office Suite and ability to operate general office machinery.
  • Good written and verbal communication skills, presentation, and interpersonal relationship skills.
  • Good problem-solving and critical thinking skills.
What We Offer:
  • Competitive compensation and benefits package.
  • Flexible working hours and remote working.
  • Pension plan and insurance.
  • Meal benefits and service awards.
  • Leave benefits and transportation benefits.
  • Employee stock purchase program and employee assistance program.
  • Comprehensive wellness program including onsite gym, yoga classes, and massage.


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