Job Description
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...
- 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...