Job Description
This role is accountable for performance and compliance for assigned protocols in a country in
compliance with ICH/GCP and country regulations, our company policies and procedures, quality
standards and adverse event reporting requirements internally and externally.
Under the oversight of the Head COMs, the person is responsible for
execution and oversight of clinical trial country submissions and
approvals and to ensure Site Ready.
Responsibilities include, but are not limited to:
- Executes and oversees clinical trial country submissions and approvals for assigned protocols.
- Develops local language materials including local language Informed Consents and
translations.
Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
- Manages country deliverables, timelines and results for assigned protocols to meet country
commitments.
Responsible for quality and compliance in assigned protocols in country.
- Contrib...