• Leadership & Impact: Provide specialized data review and cleaning services for sponsors, ensuring accuracy and compliance for regulatory submissions.
• SWAT Monitoring: Implement targeted monitoring strategies to rapidly identify site or data challenges, coordinating corrective actions to maintain high-quality standards.
• Regulatory Readiness: Collaborate with sponsor teams to finalize data packages in accordance with GCP, FDA, and ICH guidelines, supporting timely, inspection-ready submissions.

• Leadership & Impact: Managed complex Phase III oncology trials spanning 230+ global sites and enrolling 1,200+ patients.
• Team Training: Trained and mentored global CRO monitoring teams, standardizing best practices and ensuring high-quality oversight.
• Regulatory Submissions: Served as the primary point person for EUCTR submissions and actively managed IVDR submissions, ensuring full regulatory compliance.
• Process Improvement: Developed audit-ready processes and coordinated regulatory submissions (EU CTR, FDA, IVDR), driving smooth post-inspection follow-ups.
• Vendor Management: Oversaw vendor and CRO relationships, ensuring projects met budget, timeline, and quality expectations.

• 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.
• Enhanced communication with investigators and cross-functional teams to proactively address operational risks.
• Introduced process improvements that boosted monitoring efficiency and audit readiness.

• 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.
• Played a pivotal role in preparing sites for audits and inspections.

• 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.
● • Strengthened sponsor-site relationships through proactive oversight, targeted training initiatives, and regular cross-functional review meetings.
● • Effectively managed study timelines, resource allocation, and risk mitigation strategies to ensure projects were completed on time and within budget.

• 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 to drive efficient trial execution.
● • Developed and executed comprehensive monitoring strategies that significantly improved site performance, optimized patient recruitment, and enhanced inspection readiness.
● • Collaborated with internal stakeholders to identify risks and implement mitigation plans, ensuring seamless study progression from start-up to database lock.

• 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, continuous communication with stakeholders to ensure study objectives were met.
● • Facilitated cross-functional collaboration to streamline processes, contributing to the efficient and timely completion of complex clinical trials.

• 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.

(Various Organizations 2004 – 2015)
● • 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.