Omotayo (Tayo) Adeagbo
Overview
9
9
years of professional experience
Work History
Lead/Senior Clinical Research Associate
Astra Zeneca
04.2017 - Current
- I conducted site initiation visits, Routine monitoring visits and Close out visits as designated in the Monitoring plan
- Currently the lead CRA for 2 oncology studies (non-small cell Lung Cancer and Breast)
- I work in proximity with both Global and local study team to track study progress and manages study sites and study related activities including but not limited to site feasibility, selection, start up, subject recruitment, enrollment, study manage
- Provide training for new CRAs, provide support for new CRAs and conduct site accompany visit with new CRA to sign them off
- Provide oversight function for junior CRAs and create performance optimization plan where needed
- Working in close contact with KOL sites to provide assistance and resolve sites specific issues
- Review and provide detailed feedback on trip reports and conduct 1:1 meeting with CRAs where needed
- Provide training and ongoing support for new CRAs, and conduct oversight visit with new CRA to sign them off
- Ensure all study milestones (IDMCs and Interim analysis) are met in accordance to study timelines by providing support and coverage to CRAs
- Providing onboarding trainings (VCV super user) to new company employees.
Clinical Research Associate
Quintiles (IQVIA)
11.2015 - 12.2016
- I conducted site initiation visits, Routine monitoring visits and Close out visits as designated in the Monitoring plan
- Ensure all study deliveries (SDV, IP accountability, query resolution) in accordance with the study timelines
- Assisted and ensure all IRB submissions/approvals and correspondences are current and updated in the site regulatory binder and sponsors eTMF
- Provide assistance with any Vendor related issues and assess
- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with SOPs, FDA, ICH, and GCP regulations
- Escalate any consistent issue and follow-up on all detrimental subject safety issues and any ICH-GCP noncompliance to my study lead
- Retrieval of completed forms, timely completion of follow up letter and trip reports and maintaining up to date eTMF.
Education
MSC Pharmaceutical Chemistry -
New Jersey Institute of Technology
05.2013
MSC. Organic Chemistry -
University of Lagos
08.2008
B. Tech Industrial Chemistry -
Federal University of Technology Akure
10.2006
Skills
- 8 years of current and independent clinical trial monitoring experience with minimal supervision
- 25 years of recent Lead CRA experience
- Strong knowledge in risk-based quality management of trial sites
- Ability to travel up to 85% nationwide
- CTMS: Impact, CLin PLus and Veeva
- EDC: Rave, IBM and inform
- Strong knowledge of ICH GCP guidelines
- Both CRO and pharmaceutical company experience
- Micro soft Office Applications (Word, Teams, Excel, PowerPoint and one note) and SharePoint
- Attention to details
- Detail oriented
- Good interpersonal and relational skills
- Problem resolution
- Good team player and adapt to change efficiently
- Willingness to learn and get mentored
- Conflict resolution abilities
- Reviewing data standards
- Report Writing
- Site Management
- Trip reports
- Protocol development
- Monitoring visits
- Medical terminology fluency
- Action planning
- Regulatory Compliance Knowledge
- Adverse event reporting
- Organizational capabilities
- Clinical Study Design
- Site monitoring expertise
- Investigator relations
- Quality Assurance Techniques
- Therapeutic Area Expertise
- ICH-GCP guidelines
- Study documentation mastery
- Clinical trial management
- Informed Consent Process
- Data Management Proficiency
- Electronic Data Capture Systems
- Team Leadership Qualities
- Vendor Management Experience
- Case report management
- Research experience
- Trial oversight
- Records Maintenance
- Scheduling proficiency
- Documentation requirements
THERAPEUTIC EXPERIENCE
· Oncology: Bladder cancer (MIBC, Phase II and III), Lung cancer (NSCLC) (First Line treatment and EGFR mutation positive) III), Breast cancer (Phase II and III), Esophageal cancer (Phase III), etc.
· Hematology: CLL (without Del (17p or TP53)
· CNS: (Neurological Disorder, Phase I)
· Cardiovascular: Hypertension (Phase III)
· Respiratory: Nasal Polyposis III
EDC EXPERIENCE
- Medidata Rave
- IBM (Delta)
- CLIN plus
- VCV - Veeva Clinical Vault.
- Impact
- Lab links
- Covance
- PDMS
- EPIC
- ETMF
- EPRO
- Signant Health
- IXRS
- Cerner
- Florence
RBQM PLATFORMS
- Smart Trials
- Action Dashboard
REFERENCES
Available on request
Timeline
Lead/Senior Clinical Research Associate
Astra Zeneca
04.2017 - Current
Clinical Research Associate
Quintiles (IQVIA)
11.2015 - 12.2016
MSC Pharmaceutical Chemistry -
New Jersey Institute of Technology
MSC. Organic Chemistry -
University of Lagos
B. Tech Industrial Chemistry -
Federal University of Technology Akure
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