Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

James Gbakinro

Richmond

Summary

Dynamic Clinical Data Manager with extensive experience at ICON - PRA Health Sciences, excelling in database design and risk management. Proven track record of achieving 98% on-time database delivery while mentoring teams to enhance productivity. Skilled in Medidata RAVE and committed to maintaining regulatory compliance and data integrity throughout clinical trials.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Clinical System Lead / Senior Clinical Data Manager

ICON - PRA Health Sciences
08.2022 - 09.2025
  • Orchestrated end-to-end CDM lifecycle management for 12+ multi-phase clinical trials across ophthalmology and CNS therapeutic areas, achieving 98% on-time database delivery and maintaining zero critical audit findings over 36 months
  • Designed and implemented 15+ complex clinical databases using Medidata RAVE and Veeva Vault EDC platforms, incorporating advanced edit check logic and CDISC SDTM standards that reduced data queries by 35% and improved data quality metrics
  • Conducted comprehensive User Acceptance Testing (UAT) protocols for 20+ database builds, identifying and resolving 200+ system issues pre-launch, resulting in 100% successful go-live implementations without critical post-deployment fixes
  • Authored and reviewed 25+ study-specific CDM documentation including Data Management Plans, CRF Completion Guidelines, and EDC specifications, ensuring 100% regulatory compliance and successful FDA audit outcomes
  • Established robust vendor oversight framework for 5+ CDM vendors, implementing standardized monitoring processes and KPI tracking that improved vendor performance scores by 40% and reduced escalation incidents by 60%
  • Implemented proactive risk management strategies identifying 50+ potential study risks through protocol analysis and timeline forecasting, developing mitigation plans that prevented 90% of identified risks from impacting study milestones
  • Maintained comprehensive TMF documentation standards across all assigned studies, achieving 100% inspection readiness and zero TMF-related findings during regulatory inspections
  • Mentored and supervised 8+ junior CDM staff members, developing individualized training programs that increased team productivity by 30% and reduced turnover by 50% through enhanced skill development initiatives

Project Data Manager, Clinical Data Management

Pham-Olam International (Allucent Pharmaceuticals)
12.2020 - 08.2022
  • Executed database soft lock and hard lock procedures for 18 clinical studies within established timelines, achieving 100% milestone compliance and enabling timely statistical analysis initiation
  • Led FSP DM teams across 10+ concurrent studies, conducting weekly study meetings and delivering comprehensive metrics reporting that improved stakeholder visibility and decision-making efficiency by 45%
  • Designed and developed 12+ eCRF specifications and matrices using industry standards, implementing dynamic queries and validation rules that reduced data entry errors by 40% and improved site user experience
  • Managed cross-functional integration of laboratory data and analyte ranges in RAVE/Inform systems, successfully configuring 200+ lab parameters and establishing automated reconciliation processes
  • Collaborated with Database Administrators on complex study database architectures, creating validation protocols and dummy data sets that ensured 100% accuracy in edit check programming and screen functionality
  • Established process improvement initiatives including new resourcing models and streamlined CRF draft processes, reducing turnaround times by 35% and improving operational efficiency across multiple therapeutic areas
  • Provided training and mentorship to offshore team members in India, developing comprehensive training materials and quality assurance protocols that improved query resolution accuracy by 50%

Senior Clinical Trial Manager / Data Manager

Trial Form Support (TFS)
07.2016 - 11.2020
  • Managed clinical and data management operations for 15+ studies simultaneously, overseeing budget execution, monitoring plan development, and achieving 95% enrollment targets within projected timelines
  • Performed comprehensive data review and quality control activities, maintaining 99.5% data accuracy rates through systematic CRF audits and implementing corrective action plans for data discrepancies
  • Developed and maintained study-specific procedures and documentation, ensuring 100% GCP compliance and successful regulatory inspection outcomes across all assigned studies
  • Executed SAE reconciliation processes between safety and clinical databases, maintaining real-time data integrity and achieving zero safety reporting delays through automated reconciliation protocols
  • Implemented advanced data management processes including diagnostic programs and reconciliation listings, improving data review efficiency by 50% and reducing query resolution times
  • Coordinated with independent readers and site personnel for data extractions and IND alert mailings, maintaining 100% communication accuracy and timely regulatory correspondence
  • Established quality control frameworks for clinical trial databases, achieving 98% accuracy rates against source documents and implementing standardized audit procedures

Clinical Data Manager

Syneos Health
03.2014 - 06.2016
  • Managed data management operations for 8+ Phase II/III clinical trials in oncology and infectious disease therapeutic areas, ensuring adherence to CDISC standards and regulatory requirements
  • Designed clinical study databases using Oracle Clinical and Inform systems, implementing validation rules and edit checks that improved data quality and reduced query rates by 30%
  • Performed comprehensive CRF data reviews for completeness and accuracy, generating and resolving 500+ data queries monthly while maintaining high data quality standards
  • Collaborated with biostatistics teams on database design and data transfer activities, ensuring seamless integration of clinical data for statistical analysis and regulatory submissions
  • Developed training materials and conducted site training sessions on EDC systems, achieving 95% user proficiency rates and reducing data entry errors
  • Maintained comprehensive study documentation and TMF files, ensuring 100% regulatory compliance and audit readiness throughout study lifecycles
  • Implemented quality assurance procedures for data management activities, establishing standardized workflows that improved team efficiency by 25%

Clinical Research Associate

PPD (Pharmaceutical Product Development)
01.2012 - 02.2014
  • Conducted site qualification and initiation activities for 20+ investigative sites, ensuring protocol compliance and successful study startup within established timelines
  • Performed routine monitoring visits and data review activities, identifying protocol deviations and implementing corrective action plans that maintained study integrity
  • Coordinated IRB/ethics committee submissions and regulatory documentation, achieving 100% approval rates and maintaining compliance with local regulatory requirements
  • Managed trial master file documentation and regulatory file maintenance at investigative sites, ensuring audit readiness and regulatory compliance
  • Supported study supply logistics and bio-specimen management activities, maintaining chain of custody and ensuring sample integrity for laboratory analysis
  • Developed and maintained strong relationships with principal investigators and site staff, facilitating effective communication and study execution
  • Contributed to internal quality compliance initiatives and departmental process improvement efforts, enhancing operational efficiency and data quality standards

Education

Master of Arts - International Project Management

Middlesex University
05.2011

Bachelor of Science - Biomedical Engineering

University of Texas
05.2009

Skills

  • Medidata RAVE
  • Veeva Vault EDC
  • Oracle Clinical
  • Inform EDC
  • CDISC Standards
  • CDASH
  • SDTM
  • GCP Guidelines
  • ICH Guidelines
  • CFR Part 11
  • User Acceptance Testing
  • Database Design
  • Edit Check Logic
  • Data Management Plans
  • CRF Design
  • Query Management
  • Database Lock
  • SAS Programming
  • SQL Developer
  • Advanced Excel
  • Pivot Tables
  • SharePoint
  • TMF Management
  • Vendor Oversight
  • Risk Management
  • Study Metrics
  • Data Analytics
  • Process Improvement

Certification

  • Project Management Professional (PMP)
  • Certified Business Analysis Professional (CBAP)
  • SAFe 6.0 Release Train Engineer (RTE)
  • SAFe 6.0 Solution Architect (SSM)
  • Certified ScrumMaster (CSM)
  • Professional Scrum Master (PSM)

Timeline

Clinical System Lead / Senior Clinical Data Manager

ICON - PRA Health Sciences
08.2022 - 09.2025

Project Data Manager, Clinical Data Management

Pham-Olam International (Allucent Pharmaceuticals)
12.2020 - 08.2022

Senior Clinical Trial Manager / Data Manager

Trial Form Support (TFS)
07.2016 - 11.2020

Clinical Data Manager

Syneos Health
03.2014 - 06.2016

Clinical Research Associate

PPD (Pharmaceutical Product Development)
01.2012 - 02.2014

Master of Arts - International Project Management

Middlesex University

Bachelor of Science - Biomedical Engineering

University of Texas

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James Gbakinro