Elias Onyoh

Skills

GMP & GCP Compliance
• Familiarity with GMP and GCP regulations
• SOP-driven workflow adherence
• Inspection and audit readiness support
• Controlled document management and version tracking

Quality & Documentation Control
• QC review of clinical and regulatory documents
• Identification and correction of documentation inconsistencies
• Regulatory submission support (IND, IRB continuing review)
• Deviation awareness and compliance documentation

Pharmacovigilance & Patient Safety
• Patient safety narrative drafting
• Adverse event language review
• Safety section QC for regulatory documents
• Awareness of ICH safety reporting standards

Clinical Trial Operations
• Regulatory binder maintenance
• CRF review and documentation support
• Cross-functional coordination with clinical operations and data teams
• Trial start-up and amendment documentation support

Technical Tools
• Microsoft Office Suite, SharePoint, Adobe Acrobat
• eTMF and EDC systems (user-level familiarity)
• IRB submission portals
• Basic SAS, SPSS, and R (data review support)

About

Clinical research and regulatory professional with hands-on experience supporting GCP-compliant clinical trials, safety documentation, and regulatory submissions in oncology and infectious disease studies. Background includes document quality review, regulatory coordination, patient safety narrative drafting, and trial operations support within SOP-driven environments. Experienced collaborating across operations, data, and regulatory teams to ensure compliance, documentation integrity, and inspection readiness. Seeking an entry-level industry role in Manufacturing Operations, Quality Assurance, Pharmacovigilance, or Clinical Trial Operations to build long-term pharmaceutical experience and grow within a GMP-regulated organization.