Regional Clinical Study Manager

Supports Senior Director to build Japan organization and required process such as Local SOP and WI.

Conducts Country level feasibility.

Supports country activity for new studies until reginal/ country COM is identified.

Supports Senior Director for vendor management for FSP partner/ Full Outsourcing in Japan.

Oversees FSP studies performance in Japan.

Improves FSP’s study execution process in Japan in collaboration with FSP partner.

Maintains FSP Quality Metrics.

Takes onboarding actions for FSP new hires.

Oversees and support regional COM for Japan specific regulations and tasks.

Takes trial management responsibility if required.

Conducts Site Motivation visits and Study Oversight Visits for all studies in Japan.

Prepares and supports PMDA inspection

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