Michael Omogberha

Facilitated day-to-day management of operational aspects for low to medium complex clinical trials, including oversight of clinical sites and vendor management. Managed study start-up activities, regulatory submissions, and document tracking in eTMF, ensuring compliance with ICH-GCP and SOPs. Collaborated with cross-functional teams, monitored site performance, and contributed to clinical study pl

Managed all clinical aspects of global Phase I-III oncology trials, including budget, metrics, and operations. Assessed and managed CROs and vendors, oversaw site training, and ensured compliance with protocols and ICH/GCP guidelines. Developed study documents, managed TMF and internal files, participated in audits, and mentored junior team members.

Monitored investigator sites using a risk-based approach, ensuring data accuracy through SDR, SDV, and CRF review. Assessed investigational product, documented observations in reports, and escalated issues to management. Maintained regular contact with sites, managed investigator payments, and ensured compliance with monitoring plans, protocol, regulatory requirements, and ICH GCP.

Conducted qualification, initiation, monitoring, and termination visits at clinical sites, building relationships and ensuring study integrity. Reviewed trial performance, safeguarded patient rights, and developed recruitment strategies. Evaluated data quality, site efficacy, and drug accountability, managing site activities across multiple protocols and therapeutic areas while ensuring compliance

Conducted interim monitoring visits and ISF reviews, clarifying and obtaining data changes via query resolutions. Prepared various site visit reports and follow-up letters, documenting site status and activities. Managed SAEs, safety documentation, and pregnancies, facilitated investigator payments, and maintained clinical trial tracking information while ensuring compliance with trial documents a

Collaborated with Territory Managers to ensure case coverage and favorable clinical outcomes, providing technical assistance and support. Assisted in educational and training activities for physicians and staff, staying updated on clinical data and competitor products. Addressed inquiries, provided technical support including imaging modalities and hemodynamic waveforms, and managed product invent

Understood and followed institutional SOPs, reviewing protocols for clarity and feasibility. Ensured training and study requirements were met, assisted with recruitment planning and execution, and attended investigator meetings. Coordinated site visits, assisted in source document creation, ensured adequate supplies, and reviewed lab results and test results for completeness and alerts.