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.

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