Director of Clinical Operations


New job

Aria CV, Inc.

2018-10-19 16:37:55

Job location Saint Paul, Minnesota, United States

Job type: fulltime

Job industry: Executive Positions

Job description

Responsibilities

  • Interface with a multi-faceted clinical project team including clinical and regulatory consultants, biostatistics, data management and clinical monitors to achieve successful clinical studies
  • Ensures SOPs/clinical quality system exists and is maintained to meet compliance with clinical protocols, GCP, applicable global regulations
  • Develop protocols, informed consent documents, investigator brochures, case report forms, study manuals and other study related tools
  • Initiate and manage study sites including site personnel and data oversight, while maintaining protocol and regulatory compliance
  • Provide support with field clinical investigations. Support site education regarding clinical usage of company products

Qualifications
  • Bachelor's degree in a scientific related discipline, life sciences, engineering, or related field.
  • Minimum of 8 years broad Senior CRA or Clinical Project Manager experience, including the management of CROs
  • Experience with implantable cardiology related products and technologies
  • Experience in managing pre-market device studies during the feasibility and pivotal IDE phase
  • Knowledge of FDA/EU regulations and Good Clinical Practices essential; familiarity with Quality System
  • Proficient in project management and clinical research in a lead position in the IDE/medical device arena

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