Philip Ndoki

WORK HISTORY

EDUCATION

ABOUT PHILIP NDOKI

I am a certified Sr. Clinical Research Associate (CCRA-certified) and Epidemiologist with nearly a decade of experience monitoring Phase I–IV clinical trials for CROs and pharmaceutical sponsors. My expertise includes conducting Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV), with a strong focus on ICH-GCP compliance, protocol adherence, data integrity, and patient safety. I have a proven track record of ensuring audit readiness, resolving site issues, and maintaining high-quality clinical trial execution across diverse research sites. I have supported studies across multiple therapeutic areas, including oncology, vaccines, neurology (CNS), infectious diseases, respiratory conditions, dermatology, rare diseases, and medical devices. My background in epidemiology and biostatistics strengthens my ability to interpret clinical data, evaluate endpoints, and support evidence-based decision-making throughout the trial lifecycle. Earlier in my career, I spent over 16 years in academia, which enhanced my ability to train site staff, communicate complex concepts clearly, and build strong working relationships with investigators and study teams. Core Competencies: Clinical Trial Monitoring | ICH-GCP | FDA Regulations | Site Management | eTMF | Risk-Based Monitoring | Protocol Compliance | Query Resolution | Audit Readiness | CRO/Sponsor Collaboration I am passionate about advancing clinical research through quality monitoring, regulatory excellence, and efficient trial execution.