Jack Donnelly

Background

About Jack Donnelly

Clinical Project Manager with over 6 years of experience leading global clinical research studies, specializing in dermatology, personal healthcare, and OTC product trials. I manage full clinical trial lifecycles—from protocol development and IRB/ethics submissions to regulatory compliance, TMF oversight, AE reporting, and final clinical reporting—across the U.S, U.K, and Thailand. I bring in-depth regulatory knowledge across ICH-GCP (E6 R2), FDA 21 CFR, ISO and OTC Monograph guidelines. In my current role as Technical Director, I support clinical project teams across international sites, contribute to protocol design and feasibility, implement electronic systems, and ensure alignment with evolving FDA, ISO, and ICH regulations. My certifications include ICH-GCP (TransCelerate-accredited), NIH Principles of Clinical Pharmacology, and CPD-accredited diplomas in drug discovery and project management. I also have hands-on experience with IRB coordination, cross-functional team training, and study setup from site selection through close-out. Passionate about high-quality trial execution, regulatory accuracy, and patient-centered research, I continue to support trials that bridge personal healthcare innovation with robust clinical methodology.