The Clinical Operations Manager role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Responsibilities

• Execute and oversee clinical trial country submissions and approvals for assigned protocols.
• Develop local language materials including local language Informed Consents and translations. Interact with IRB/IEC and Regulatory Authority for assigned protocols.
• Manage country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
• Contribute to th...