**Job Responsibilities:**

+ Perform feasibility, site identification, site contract negotiation, and other study start-up activities, as assigned. Distribute and collect CDAs for potential study sites.
+ Provide country-specific study start-up expertise to study start-up team leads and project teams. Create study start-up document templates.
+ Responsible for the preparation and coordination of submissions to regulatory, ethics, and other bodies.
+ Develop, finalize, and review master and country-specific subject information sheets (SIS)/ICFs.
+ Review and translate drug labels.
+ Perform independent quality review of submission packages.
+ Responsible for the translation and coordination of translations for documents required for submission.
+ Perform timely and accurate data entry of all relevant study start-up activities into the appropriate CTMS.
+ Copy and route incoming correspondence, internal documentation, etc, as appropriate.
+ Responsible ...