Godfrey Coker
San Diego
Summary
Strategic Clinical Project Manager with 5+ years leading therapeutic clinical trials through all phases - from feasibility and site selection through inspection readiness and closeout. Expert in ICH/GCP compliance, cross-functional team leadership, vendor oversight, and global study coordination delivering zero inspection findings and 98% protocol adherence. Proven in driving operational excellence, data quality, and patient-focused strategies across multi-site programs.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Product Inspector, RMA Department
Masimo Corporation
Irvine
10.2025 - Current
- Conducted FDA/GMP quality inspections on returned clinical devices, ensuring regulatory compliance and audit readiness for successful audits
- Analyzed defect trends and implemented CAPA with engineering teams, enhancing quality processes for clinical devices
- Maintained precise documentation to support quality assurance and inspection preparation for clinical operations
Diagnostic Radiology Research Manager
Los Angeles
02.2024 - 09.2024
- Led YUNU therapeutic trial imaging data delivery achieving 98% tumor read efficiency (48%→98%) across study lifecycle
- Directed cross-functional teams managing clinical data collection, analysis, and site monitoring per protocol timelines
- Implemented workflow optimization ensuring ICH/GCP compliance and data quality standards
Senior Clinical Trials Program Manager
Mount Sinai Icahn School of Medicine – Neurology
San Diego
09.2023 - 02.2024
- Oversaw multiple therapeutic trials ensuring on-time completion, budget adherence, zero inspection findings
- Managed CRO/vendor performance from study startup through closeout including inspection readiness activities
- Conducted site monitoring, protocol compliance oversight, and cross-functional issue escalation
Senior Clinical Trials Manager
NCIRE – Northern California Institute for Research and Education
San Francisco
10.2022 - 09.2023
- Directed global site feasibility, vendor selection, and study startup aligning with sponsor timelines/budgets
- Maintained GCP/SOP compliance preparing audit-ready Clinical Trial Master Files for VA R&D inspections
- Optimized cross-functional study communication and resource allocation driving operational efficiency
Clinical Trials Manager
Pulsen-More
Beverly Hills
03.2022 - 12.2022
- Executed ICH/GCP clinical trial operations ensuring data integrity, subject protection, federal compliance
- Managed investigator recruitment, informed consent processes, and study budgets improving enrollment efficiency
Clinical Trials Manager
Alzheimer's Therapeutic Research Institute
San Diego
04.2019 - 10.2022
- Achieved 264% participant diversity increase across 13 sites through ADNI3 Taskforce site engagement strategies
- Coordinated 60+ IRBs streamlining submission timelines and maintaining global protocol compliance
- Led monitoring plans, KPI tracking, and cross-functional collaboration across international study sites
Education
Master of Social Science - Entrepreneurship
University of Southern California
01.2020
Master of Public Health - Public Policy
University of Southern California
01.2019
Master of Business Administration - Hospital Finance
Indiana Wesleyan University
01.2015
B.S. - Industrial Engineering Technology / Industrial Distribution
Purdue University
Skills
- Clinical Trial Management (CTMS, CPM)
- ICH/GCP Regulatory Compliance
- Cross-Functional Team Leadership
- Vendor & CRO Oversight
- Global Site Feasibility & Selection
- Risk Mitigation & Issue Escalation
- Budget & Timeline Management
- Inspection Readiness Activities
- Data Review & Quality Oversight
Certification
- Clinical Trial Management Certificate, PHRP Online Training, 2022
- Biomedical Human Subjects & Good Clinical Practice (US FDA focus), PHRP, 2022
- SMART-TRIAL Intuitive Interface Regulation Compliance, PHRP, 2023
- CITI: Protecting Human Research Participants, 2024
Accomplishments
- 98% tumor read efficiency through clinical process redesign and cross-functional training
- 264% participant diversity growth across 13 global sites in 6 months
- Zero inspection findings delivering 98% protocol compliance through risk mitigation
- 50% trial data accuracy improvement via structured monitoring and quality oversight
Websites
Timeline
Product Inspector, RMA Department
Masimo Corporation
10.2025 - Current
Diagnostic Radiology Research Manager
02.2024 - 09.2024
Senior Clinical Trials Program Manager
Mount Sinai Icahn School of Medicine – Neurology
09.2023 - 02.2024
Senior Clinical Trials Manager
NCIRE – Northern California Institute for Research and Education
10.2022 - 09.2023
Clinical Trials Manager
Pulsen-More
03.2022 - 12.2022
Clinical Trials Manager
Alzheimer's Therapeutic Research Institute
04.2019 - 10.2022
Master of Social Science - Entrepreneurship
University of Southern California
Master of Public Health - Public Policy
University of Southern California
Master of Business Administration - Hospital Finance
Indiana Wesleyan University
B.S. - Industrial Engineering Technology / Industrial Distribution
Purdue University