Teams at Otsuka America Pharmaceutical

Lead design and implementation of process improvement initiatives for global clinical operations. Develop SOPs, process maps, KPIs, and training materials. Drive adoption of CoE standards, partner with cross-functional teams and external vendors, support change management, and ensure compliance with GCP/ICH and QMS requirements to improve trial efficiency, quality, and scalability.

Lead design and implementation of process improvement initiatives across global clinical operations. Identify inefficiencies, develop SOPs and training, define and monitor KPIs, analyze performance data, drive change management and stakeholder engagement, partner with internal teams and external vendors, ensure GCP/ICH compliance, and support QMS/CAPA efforts to enhance operational efficiency and quality.

Manage end-to-end relationships with assigned clinical vendors, oversee governance, CTMS maintenance, onboarding, metrics and scorecards, resolve escalations, support vendor qualification/audits, develop portfolio templates/handbooks, and coordinate internal stakeholder communications to ensure contractual and performance compliance.