Jeremy Onoriode
Houston,TX
Summary
Dynamic Senior Clinical Trial Manager with extensive experience at AbbVie, specializing in oncology and cardiovascular trials. Achieved significant cost savings through strategic vendor negotiations and enhanced site performance, ensuring compliance and audit readiness. Proficient in regulatory submissions and risk mitigation, complemented by strong leadership and communication skills.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Senior Clinical Trial Manager
AbbVie
07.2023 - Current
- Designed and executed Phase I-II oncology and cardiovascular device trials across 50+ global sites, ensuring 100% regulatory compliance.
- Streamlined site activation by 25%, aligning study goals with organizational objectives.
- Implemented RBQM strategies, reducing monitoring costs by 20% while maintaining inspection readiness.
- Led financial oversight, ensuring budget adherence and escalating variances to senior management.
Senior Clinical Trial Manager
AstraZeneca
04.2021 - 03.2023
- Oversaw Phase I-II immunotherapy and cardiovascular trials, including protocol development and IND applications.
- Negotiated vendor contracts, achieving $400K annual cost savings without compromising quality.
- Enhanced site performance, reducing protocol deviations by 30%, ensuring audit readiness.
Clinical Trial Manager
Abbott Laboratories
05.2018 - 04.2021
- Managed Phase I-III rare disease and cardiovascular device trials across 35+ sites.
- Reduced protocol violations by 30% through proactive risk mitigation.
- Led IRB submissions, accelerating approval timelines by 15%.
Senior Clinical Research Associate
Sanofi
07.2014 - 05.2018
- Conducted on-site monitoring for oncology and rare disease trials, ensuring GCP compliance.
- Mentored new CRAs, maintaining inspection-ready documentation.
Clinical Research Associate
Novartis
03.2011 - 07.2014
- Supported regulatory inspections and audits, developed monitoring plans, and conducted site feasibility assessments.
Clinical Study Coordinator
Georgia Tech Research Institute
09.2009 - 03.2011
- Led participant recruitment, surpassing enrollment targets by 20%.
Education
Bachelor of Science - Pharmacy
University of Port Harcourt
Skills
- Oncology
- Rare Diseases
- Cardiovascular Devices
- Hematology
- Immunology
- ICH-GCP
- FDA CFR Part 11
- EU Clinical Trial Regulation (CTR)
- IND/CTA submissions
- Health Care Compliance (HCC)
- TMF management
- Inspection readiness
- Audit preparation
- Document control
- CROs
- Central labs
- Imaging vendors
- EDC/eCOA systems
- Protocol development
- Feasibility
- Site selection
- Timeline and budget management
- ECRFs
- EDC systems
- Data cleaning
- Metrics reporting
- UAT
- Budget negotiation
- Vendor contracts
- Financial forecasting
- Costsaving initiatives
- RBQM
- Risk identification
- Mitigation planning
- CRA/site staff training
- Protocol adherence
- Team development
- Veeva Vault
- Medidata Rave
- Redcap
- JMP
- Tableau
- MS Project
- Smartsheet
- Regulatory compliance
- Project management
- Risk assessment
- Site management
- Vendor negotiation
- Data analysis
- Effective communication
- Time management
- Problem solving
- Training and mentoring
- Document review
- Clinical trial oversight
- Patient recruitment
- Feasibility analysis
- Clinical monitoring
- Data management
- Good clinical practice
- Investigational product handling
- Informed consent process
- Case report form completion
Certification
- Certified Clinical Research Professional (CCRP)
- Project Management Professional (PMP)
- Good Clinical Practice (GCP) Certification
- Risk-Based Monitoring (RBM) Specialist
Accomplishments
- Published work on data integrity in global trials.
- Speaker at DIA Annual Meeting on clinical trial diversity.
- Developed departmental SOPs to enhance compliance & efficiency.
Timeline
Senior Clinical Trial Manager
AbbVie
07.2023 - Current
Senior Clinical Trial Manager
AstraZeneca
04.2021 - 03.2023
Clinical Trial Manager
Abbott Laboratories
05.2018 - 04.2021
Senior Clinical Research Associate
Sanofi
07.2014 - 05.2018
Clinical Research Associate
Novartis
03.2011 - 07.2014
Clinical Study Coordinator
Georgia Tech Research Institute
09.2009 - 03.2011
Bachelor of Science - Pharmacy
University of Port Harcourt
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