Senior Manager of Clinical Strategy

Job Description
- Clinical Strategy & Protocol Development
 o Lead the development of IRB and clinical study protocols in alignment with company objectives.
 o Collaborate with surgeons and clinical advisors to design impactful studies that address business and clinical needs.
 o Participate in the overall clinical strategy planning process, including statistical analysis plans and protocol review cycles.
 o Submit and manage regulatory applications (FDA and other global agencies).
- Clinical Execution & Oversight
 o Oversee clinical study activities including site selection, investigator engagement, initiation, monitoring, and study closeout.
 o Ensure studies are conducted in compliance with approved protocols, regulatory standards, and timelines.
 o Perform site visits, oversee test article reconciliation and disposition, and maintain accurate documentation.
- Data Integrity & Reporting
 o Ensure the accurate transmission and validation of clinical d...