Tatsuya Inomata

• Led project delivery requirements for the software development lifecycle with internal and external global stakeholders for domestic/international clients.
• Managed scoping, budgeting, forecasting, timelines, risk management, solving issues, milestone tracking, reporting, change management and control to deliver quality deliverables.
• Responsible for financial health of the assigned projects, including licensing, payments, invoicing, devices, logistics, resource assignments and vendor management activities.
• Drove change control and risk management for project systems, aligning releases with client expectations and quality management governance.
• Served as a primary client contact throughout projects.
• Responsible for reporting project status updates and issues to higher management and clients.
• Collaborated with global cross-functional teams (Engineering, Linguistic, Licensing, Clinical, Quality, and Operation) to ensure compliance with quality and regulatory standards.
• Successful 6.5 years of full remote work across client meetings, go-live support, training for new employees, and product support throughout ongoing projects.

Mr Gay Japan is a gay pageant event to find a spokesperson in order to promote visibility and raise awareness of LGBTQ+ in Japan.

• Successful planning and coordination of workshops, content creation, events, and press relations with external partnerships such as NPOs, lawyers, food providers, photographers, journalists and venue providers.
• Created from 0 to 1, building relationships with external organizations and managing social media content with intended SEO.
• Responsible for communications with global organizations to share insights on LGBTQ+ Japan and participation in the Mr Gay World competition.

• Directed global communication and task planning for material development in high fashion, keeping stakeholders aligned on scope and deadlines.
• Translated documents and videos for documentaries, sports, advertisements, news, and reality content with consistent language quality.
• Researched source information for sports events, TV programs, and reports to support accurate, timely content preparation.

• Completed audits and monitoring reports under GCP, ICH, and regulatory requirements.
• Monitored sites for initiations, routine visits, and closeout to maintain study quality.
• Coordinated internal, external, and global communication to align studies with sponsor expectations and site execution.
• Trained sites on protocol, regulatory, and sponsor requirements to support compliant study conduct and data reporting.
• Maintained TMF and ISF files, monitoring letters, and trial supplies with accurate, audit-ready documentation.
• Tracked enrollment, CRF completion, data query resolution, deviations, and training to keep study operations moving.
• Documented site findings and follow-up actions clearly to support timely resolution and consistent sponsor communication.

• Managed across FIH, BE, and Phase I/II/III studies.
• Coordinated site selection, activation, closing, and audit readiness through cross-department communication and stakeholder meetings.
• Adapted protocols, CFRs, IC forms, and worksheets into site-specific documents while managing change control.
• Oversaw protocol requirements and subject safety during visits, including informed consent, deviation response, AE/SAE handling, and prevention planning.
• Managed investigational product shipments, temperature control, onsite drug preparation, blind/unblind plans, and medical device calibration quality checks.
• Organized site SOP training, contract and IRB preparation, and recruitment planning to support timelines and study predictability.

• Handled BtoC and BtoB customer relations in English and Japanese, maintaining clear communication across diverse inquiries.
• Resolved maintenance support requests and complaints with professional follow-up and steady customer focus.
• Managed contract documents accurately to keep records organized and accessible for daily sales activities.
• Maintained inventory control to support product availability and smooth transaction processing.
• Contributed to sales target achievement by aligning customer support with contract accuracy and inventory readiness.