Director of Clinical Operations
Aria CV, Inc.
Saint Paul, Minnesota, United States
Job type: fulltime
Job industry: Executive Positions
- 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
- 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