Sr. Clinical Study Manager

Previous experience implementing, helping and managing medical device trials Significant knowledge of clinical and/or outcomes research study design
Proven experience in protocol and ICF development, writing clinical section(s) for regulatory submission
Proven experience in conducting literature searches, reviews and appraisal of the scientific data
Excellent ability to interact with physicians and other professionals inside and outside the company
Knowledge of Good Clinical Practice ICH/Google Cloud Platform and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
Experience negotiating clinical research contracts and budgets
Must be able to work effectively on cross-functional teams