Clinical Study Manager

Clinical Study Manager

Smith & Nephew

Baar, Switzerland

Your responsibilities

  • Assess study feasibility, collaborating with Clinical Strategy Lead through the study design process and collaborate with project team to develop clinical study protocols and associated documents
  • Train investigators, research coordinators, CROs, central laboratories and other study vendors on study related procedures
  • Plan, manage and report all aspects of global clinical studies including budgets through oversight of cross-functional study activities
  • Create and report clinical study updates to management on a regular basis; report on performance to plan
  • Coordinate and oversee clinical studies to support regulatory submissions (IDE, PMA, 510(k) and Post Market Surveillance); assist in preparation of clinical study reports, regulatory documents and submissions
  • Independently liaise with Smith and Nephew product teams and in country sales and marketing personnel to ensure effective study alignment with product strategy throughout the design, implementation and lifetime of the clinical study
  • Monitor and/or oversee monitoring by CRAs, to ensure compliance with study protocols, regulatory requirements and Smith & Nephew procedures
  • Follow current SOPs, regulations and conduct peer training on processes/procedures

Your profile

  • Bachelor’s degree in life sciences or related field or equivalent education and experience
  • Minimum 3 years’ experience in the medical device industry, clinical setting or research field
  • Study management / Project management skills
  • Demonstrate understanding and quality delivery of study milestones according to established timelines
  • Strong negotiation and professional communication skills
  • Strong oral and written English and German skills are a must
  • Advanced knowledge and application of industry standards and best practices in clinical data management and applicable country regulations (US FDA, MDR, ISO 14155:2011, ICH, etc.)

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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