Tengu Muna

Provided specialized data review and cleaning services for sponsors, ensuring accuracy and compliance for regulatory submissions. Implemented targeted monitoring strategies to rapidly identify site or data challenges, coordinating corrective actions to maintain high-quality standards. Collaborated with sponsor teams to finalize data packages in accordance with GCP, FDA, and ICH guidelines, support

Managed complex Phase III oncology trials spanning over 230 global sites and enrolling over 1,200 patients. Trained and mentored global CRO monitoring teams, standardizing best practices and ensuring high-quality oversight. Served as the primary point person for EUCTR and IVDR submissions, ensuring full regulatory compliance.

Directed clinical protocols from site feasibility through database lock, achieving key milestones on time. Designed and implemented training programs for CRAs and site staff, emphasizing risk mitigation, regulatory compliance, and data integrity. Managed clinical supplies, site budgets, and contracts in line with ICH-GCP and FDA standards.

Oversaw global site qualification, initiation, monitoring, and closeout for multiple oncology-focused therapeutic programs across APAC and North America. Developed tailored monitoring strategies to ensure protocol compliance and rapid resolution of data discrepancies. Collaborated with Data Management and Regulatory Affairs to sustain study timelines and regulatory standards.

Led global clinical trial projects across APAC, North America, and Europe, managing all study phases from protocol development to final study deliverables. Developed and implemented customized monitoring templates and corrective action plans to drive consistent study performance and ensure data integrity. Effectively managed study timelines, resource allocation, and risk mitigation strategies to e

Coordinated global trial operations across APAC and North America, ensuring rigorous adherence to study protocols and regulatory standards. Coordinated cross-functional study management teams, overseeing budget forecasting, schedule management, and quality metrics. Developed and executed comprehensive monitoring strategies that significantly improved site performance and optimized patient recruitm

Directed multi-regional clinical trial planning and execution, establishing standardized monitoring plans and best practices to improve overall study management. Optimized site engagement and resource allocation while ensuring strict adherence to SOPs, GCP, and regulatory guidelines. Proactively managed operational challenges and maintained clear communication with stakeholders to ensure study obj

Conducted extensive on-site and remote monitoring visits for source document verification and data integrity assurance. Developed and delivered targeted training modules to reinforce protocol and regulatory compliance. Collaborated with clinical operations to resolve discrepancies and boost inspection readiness.

Executed routine monitoring visits and developed robust monitoring plans across multiple therapeutic areas. Cultivated strong relationships with investigative sites, contributing to improved recruitment, retention, and study performance. Supported regulatory submissions and maintained high standards of clinical documentation and audit readiness.