Vadzim Johnson
Tampa
Summary
Senior Clinical Operations Leader with over 12 years of experience driving Phase I–III global clinical trials within Endocrinology, Immunology, Neurology, and Oncology. Expert in transitioning site-level monitoring into study-level strategy. Proven track record of shortening site activation timelines, reducing monitoring costs by 20%, and maintaining 100% inspection readiness for high-priority global programs. Seeking to leverage deep operational expertise to deliver high-quality clinical data as a Clinical Trial Manager.
Overview
9
9
years of professional experience
Work History
Clinical Research Associate (Senior/Lead Level)
Amgen FSP, Icon CRO
08.2024 - Current
- Accelerated Enrollment: Identified regional recruitment barriers for high-priority Phase III Obesity Type 2 Diabetes programs; implemented targeted site-outreach strategies that increased enrollment by 18% within the first 60 days.
- Risk-Based Monitoring (RBM): Championed RBM strategies within a large-scale Cardiovascular trial, utilizing data-driven trends to prioritize high-risk sites and reduce travel expenses by 15% without compromising data quality.
- Complex Therapeutic Oversight: Direct monitoring activities for global Phase III Immunology trials, managing high-complexity protocols for biologics and ensuring 100% adherence to specialized dosing regimens.
- Audit Excellence: Led 'Mock Audit' preparations for high-enrolling sites, resolving over 200 legacy queries and ensuring zero 'Critical' findings during a subsequent Sponsor quality audit.
- Mentorship: Provided field training for 4 junior CRAs, improving the average 'Time to Report Submission' by 50% and ensuring standardized GCP compliance across the study team.
Clinical Program Manager (Independent Consultant)
Clinical Research and Regulatory Services, LLC
11.2022 - 07.2023
- Timeline Optimization: Managed a portfolio of clinical projects, shortening the 'Site Activation' phase by 4 weeks through proactive regulatory document collection and streamlined IRB submissions.
- Strategy & Budget Oversight: Collaborated with stakeholders on study design and site selection; identified a $50k vendor invoicing discrepancy and successfully recovered funds for the study budget.
- Risk Assessment: Implemented study-wide mitigation strategies that reduced protocol deviations by 12% across multiple Phase II projects.
Global Clinical Project Assessment Manager
WCG Medavante ProPhase
05.2021 - 11.2022
- Operational Scale: Orchestrated global Neurology projects across 15+ countries, maintaining a 98% on-time milestone completion rate for study start-up and database lock.
- Digital Transformation: Directed the rollout of Decentralized Trial (DCT) tools, which enhanced patient engagement and reduced study dropout rates by 12%.
- Risk-Based Strategy: Developed a customized risk-tracking dashboard that flagged site compliance issues 30% faster than manual methods, allowing for immediate corrective action.
Institutional Review Board (IRB) Project Specialist
Baylor Scott and White Health
10.2016 - 06.2020
- Regulatory Quality: Supervised oncology and transplant projects, managing quality system audits and CAPA plans that resulted in 100% compliance with FDA 21 CFR and NIH standards.
- Process Leadership: Trained and mentored new QA auditors, improving overall department auditing accuracy and efficiency.
Education
Master of Science - Translational Pharmacology and Clinical Trial Management
Ohio State University
Bachelor of Applied Science - Healthcare Management
Polk State College
Skills
- Clinical Operations: Study Start-up, Site Activation, Risk Mitigation, Enrollment Strategy
- Compliance & Quality: ICH-GCP, FDA/EMA Regulatory Submissions, CAPA Management, Audit Prep
- Leadership: Mentoring CRAs, Cross-functional Team Leadership, Vendor/CRO Oversight
- Systems: Medidata Rave, Veeva Vault eTMF, Oracle EDC, CTMS, IWRS/IRT, Smartsheet
Websites
Timeline
Clinical Research Associate (Senior/Lead Level)
Amgen FSP, Icon CRO
08.2024 - Current
Clinical Program Manager (Independent Consultant)
Clinical Research and Regulatory Services, LLC
11.2022 - 07.2023
Global Clinical Project Assessment Manager
WCG Medavante ProPhase
05.2021 - 11.2022
Institutional Review Board (IRB) Project Specialist
Baylor Scott and White Health
10.2016 - 06.2020
Bachelor of Applied Science - Healthcare Management
Polk State College
Master of Science - Translational Pharmacology and Clinical Trial Management
Ohio State University
THERAPEUTIC EXPERIENCE
- Endocrinology: Phase II/III – Obesity and T2DM (Global).
- Immunology: Phase I–III – Lupus, Psoriatic Arthritis, Rheumatoid Arthritis, Transplant.
- Neurology: Phase III – Schizophrenia, Alzheimer’s, Dementia, Bipolar Disorder.
- Oncology: Phase II/III – Metastatic Breast Cancer, NSCLC, Pediatric Pancreatic Cancer.