Mark David Miranda, Rn, Cet Email & Phone Number

United States

• Pioneered a remote CTMS Director role, accelerating study initiation and enhancing resource management through streamlined processes. Led successful transitions from paper to eSource, increasing data management efficiency by 20%.• Ensured data integrity by providing targeted training, implementing secure access controls, and conducting focused data cleaning across CRIO’s suite of tools, including Site CTMS, eSource, eConsent, eRegulatory, and Subject Recruitment.• Streamlined site initiation and optimized eSource workflows, generating actionable reports to inform study timelines. Developed and implemented SOPs and configured eCRFs to ensure regulatory compliance.• Established a quality management system by developing rigorous documentation and control processes, aligning with regulatory standards. Delivered effective training and optimized data capture workflows to support trial success.

• Streamlined clinical trial management by fostering positive site relationships, building collaborative partnerships, and ensuring regulatory compliance. Implemented effective patient recruitment and retention strategies, prioritizing participant well-being and accurate data management.• Built and maintained strong collaborative relationships with principal investigators, study coordinators, and site personnel. Facilitated teamwork with In-House Clinical Research Associates and Regulatory Start-Up Associates to optimize project delivery and support efficient site selection and qualification.• Strengthened quality management by implementing rigorous quality control processes and ensuring meticulous adherence to project requirements and regulations. Trained junior CRAs, coordinated with teams to maintain a compliant Trial Master File (TMF), and developed robust quality management systems.• Ensured regulatory compliance by adhering to ICH-GCP guidelines and Clinical Monitoring Plan standards, managing diverse monitoring visits across trial phases. Achieved 100% Source Data Verification during critical interim database locks, demonstrating exceptional speed, accuracy, and proficiency in data management and reporting.

• Led the prestigious World Health Organization – Solidarity Trial Vaccines (WHO-STV) study as a Main Blinded Study Monitor, ensuring strict adherence to protocol, SOPs, FDA regulations, and ICH-GCP guidelines. Guided the clinical site through a comprehensive Philippine FDA inspection, achieving a satisfactory passing outcome with zero findings.• Supported rigorous compliance with FDA regulations, ICH-GCP guidelines, local policies, and standard operating procedures throughout the WHO-STV study. Monitored patient safety, managed adverse events, and ensured timely reporting.• Oversaw the execution of monitoring plan protocols by optimizing tracking forms and tools, defining visit types, frequencies, and critical tasks, and streamlining the monitoring process. Conducted meticulous data reviews and on-site monitoring visits to evaluate trial progress and ensure data accuracy.• Partnered with the site team to develop and implement effective recruitment strategies, resulting in a 12% increase in patient enrollment. Verified trial data with patient clinical notes and source documents, ensuring consistency and data integrity. Independently managed a complex workload, delivered high-quality monitoring reports, and formulated recommendations for best practices and audit preparation.

• Executed comprehensive site initiation visits and conducted on-site monitoring across diverse therapeutic areas. Ensured adherence to ICH-GCP guidelines, local regulations, and protocol requirements, while managing site and investigator selection to assess their suitability for study participation.• Trained assigned sites on protocols and study procedures, establishing effective communication channels for project management. Evaluated site practices rigorously for compliance, data integrity, and regulatory adherence, escalating quality issues and implementing risk management strategies as needed.• Managed assigned studies with a focus on efficiency, overseeing regulatory submissions, recruitment activities, CRF completion, and data query resolution. Completed 4,400 eCRF SDV pages in under 2 months with a team of 4 CRAs, achieved 100% utilization of the mobile CRA platform, and resolved critical data queries within a strict 48-hour timeframe.• Maintained meticulous documentation for site management, monitoring visits, and action plans. Collaborated effectively with study team members and provided support for project execution, demonstrating proficiency in clinical research software including CTMS, IRT/RTSM, and EDC platforms.

• Pioneered remote clinical research monitoring for US sites using the CRIO system, managed documentation, resolved queries, and secured critical regulatory approvals including IRB/IEC submissions and protocol approvals. Ensured compliance by coordinating site setup, conducting regular audits, and facilitating documentation workflows, while providing staff training to maintain adherence to regulatory standards and prepare for inspections.• Optimized study success by creating detailed process flows, developing promotional materials, and leading site setup through pre-visit coordination. Enhanced study timelines and execution while addressing sponsor inquiries and aligning with CROs/Sponsors to ensure smooth study progression.• Conducted comprehensive staff training on protocols and managed system access to ensure efficient study execution. Achieved measurable outcomes such as reducing query turnaround times and improving site readiness through streamlined workflows and risk management.• Mentored new colleagues and resolved compliance issues, handled protocol deviations, and mitigated risks with adaptability. Maintained adherence to local regulatory requirements through regular updates and active engagement with CROs/Sponsors.

• Managed Trial Master File (TMF) and Electronic Trial Master File (eTMF) across all stages—set-up, initiation, maintenance, quality control (QC), quality review (QR), query management, final reconciliation, closure, migration, and archiving—for global clinical trials (EMEA, NA, LATAM, APAC). Leveraged advanced system functionalities to ensure consistent compliance and efficient recordkeeping. Established and led a rigorous quality control review process, enhancing scientific accuracy and addressing complex regulatory challenges.• Streamlined eTMF discrepancy resolution by collaborating with cross-functional teams, achieving a 20% reduction in turnaround time for document filing. Participated in the pilot for Robotic Process Automation (RPA), contributing to a 30% reduction in manual errors and improving overall efficiency.• Maintained accurate Essential Document Lists (EDLs), ensuring inspection readiness and compliance with international regulatory standards. Monitored eTMF trends and implemented corrective actions to address emerging issues. Mentored junior team members and provided guidance on best practices for eTMF management.• Conducted comprehensive audits and addressed findings from regulatory inspections, ensuring all documents met stringent quality standards. Supported project delivery by facilitating effective communication and coordinating document flow with internal and external stakeholders.

Pasig City

• Managed and coordinated 10-11 Phase II and III clinical trials in metabolic and cardiovascular fields, exceeding enrollment targets by 25% and earning top performer recognition for exceptional recruitment rates. Implemented innovative strategies that improved patient retention by 15%.• Led cross-functional teams, optimizing participant recruitment, data collection, and regulatory adherence, resulting in 20% faster trial completion times. Fostered seamless collaboration as a trusted liaison between Principal Investigators, site staff, IRB, Sponsors, and CROs, driving successful outcomes and resolving complex issues.• Oversaw the ethical submission process and ensured full compliance with evolving local IRB standards. Maintained meticulous documentation of participant data, streamlining consent management, screening procedures, and scheduling study visits, which enhanced protocol adherence and reduced compliance issues by 30%.• Leveraged proficiency in CTMS, EDC, and RTMS platforms to ensure accurate data encoding and superior data quality and analysis. Promptly identified and addressed data discrepancies. Reported and managed Adverse Events (AE), including AESI, MAAE, TEAE, SUSAR, and SAE, ensuring timely and accurate documentation in line with regulatory guidelines.• Oversaw specimen collection and shipment, maintaining high integrity and quality. Procured and managed study drugs, provided proficient nursing care, educated study participants, and mentored new team members.

Manila

• Managed 30-50 daily patient examinations, conducting comprehensive health assessments. This included vital signs monitoring, specimen collection, and diagnostic procedures like ECGs, Ishihara color vision tests, and audio tests. Ensured accurate results were prepared for physician review. • Provided comprehensive medical histories, health education, and pre-departure advice to over 150 patients. Administered vaccines and immunizations, and efficiently facilitated medical clearance processes.• Maintained detailed medical records, collaborated effectively with physicians, and ensured accurate documentation and follow-up. Contributed to a 25% improvement in patient record accuracy. • Prepared patients for diagnostic procedures, enhancing their comfort and understanding. This resulted in a 20% reduction in patient anxiety and improved procedural compliance.

2D Echocardiography Technologist

Bs Nursing