Esther Azubike
Plano
Summary
Results-oriented Clinical Trial Manager with comprehensive expertise in managing clinical trials from site selection to study closure. Demonstrated success in developing effective monitoring plans and ensuring regulatory compliance through strong team leadership. Skilled in vendor relations and stakeholder engagement, consistently driving operational improvements and achieving project objectives.
Overview
12
12
years of professional experience
Work History
Clinical Trial Manager
IQVIA
Plano
06.2022 - Current
- Established clinical monitoring targets and ensured documentation compliance.
- Planned, prepared, and trained sites and study personnel during the Investigator Meeting.
- Managed global clinical trials to enhance operational effectiveness.
- Advocated for client interests within IQVIA to improve service delivery.
- Developed and implemented comprehensive Clinical Monitoring Plan aligned with project goals.
- Facilitated vendor selection processes while maintaining strong relationships with vendors.
- Oversaw vendor management activities, ensuring adherence to standard practices and issue resolution.
- Coordinated procurement and supply chain operations for efficient study supplies shipments.
- Streamlined clinical site needs by coordinating monitoring processes, site visits, and regulatory documentation.
- Led daily operations of clinical monitoring team, enforcing timelines and ensuring compliance.
- Effectively manages the Clinical Research Associate team, maintaining a low turnover rate and meeting study timelines on a continuous basis.
- Successfully participated in bid defenses, addressing all inquiries and questions posed by potential future clients.
Senior Clinical Research Associate III
IQVIA
Plano
07.2019 - 06.2022
- Conducted investigator site recruitment and site evaluation visits for clinical study readiness.
- Collaborated with the study startup department to prepare sites for study initiation activities.
- Obtained necessary regulatory documentation for effective trial implementation and monitoring.
- Executed study initiation by training site personnel on the protocol and all other required study processes.
- Trained site staff on study-required system functionality, and verified system access and training compliance.
- Ensured adherence to Good Clinical Practices through regular on-site monitoring visits.
- Reviewed clinical data quality via electronic CRF and source verification, resolving queries promptly.
- Performed study close-out activities, including investigational product reconciliation and file audits.
- Managed study vendors.
- Trained junior CRAs on study protocols and SOPs.
- Served as a mentor to junior CRAs.
- Managed study-required expenses and reporting.
Senior Clinical Research Associate II
Syneos Health
01.2018 - 05.2019
- Conducted site initiation visits.
- Conducted routine site visits, ensuring compliance with informed consent procedures and GCP/ICH guidelines.
- Managed assigned sites through regular communication to maintain compliance and support enrollment efforts.
- Recruited investigators for participation in clinical trials, enhancing study engagement.
- Negotiated study budgets with investigators and investigative sites to optimize resource allocation.
- Reviewed regulatory documents from investigator sites for appropriateness and compliance.
- Assessed draft protocols for feasibility and completeness before implementation.
- Verified CRFs and clinical data accuracy, generating necessary queries for resolution.
- Conducted Investigational Product (IP) reconciliation.
- Effectively conducted close out visits
- Trained junior CRAs and new research site staff on monitoring practices and clinical research regulations.
Senior Clinical Research Associate
Inventiv Health
12.2015 - 12.2017
- Executed site startup tasks, including investigator identification and evaluation visits.
- Guided new research sites in submission of regulatory documents.
- Conducted training during Investigator Meetings to enhance site understanding.
- Performed ongoing monitoring visits, ensuring compliance and data verification across investigational sites.
- Resolved queries promptly, maintaining effective communication with sites.
- Reviewed site supplies during visits to guarantee adequate resources for study conduct.
- Monitored drug inventory, compliance, and proper disposal of medications when necessary.
- Tracked site enrollment progress and collaborated on recruitment strategies.
Clinical Research Associate
Inventiv Health
12.2013 - 11.2015
- Provided management and oversight for investigational sites across multiple protocols and therapeutic areas.
- Identified and evaluated potential investigators/sites for ongoing clinical studies.
- Executed timely reporting of monitoring and administrative activities.
- Managed site personnel activities to enhance operational efficiency.
- Ensured timely data submission from study sites, including safety event reporting.
- Trained study site personnel on protocols and regulatory requirements.
- Maintained compliance with monitoring plans, SOPs, ICH Guidelines, and federal regulations.
- Facilitated regulatory inspection readiness and quality assurance audits.
Education
Master of Science - M.Sc. Public Health (MPH)
University of North Texas Health Science Center
Fort WorthBachelor of Science - Earth & Environmental Sciences.
North Carolina A&T State University
Greensboro, NCSkills
- Clinical trial management
- Vendor management
- Regulatory compliance
- Monitoring plan development
- Site recruitment strategies
- Risk management
- Project coordination
- Team leadership
- Effective communication
- Problem solving
- Training facilitation
- Stakeholder engagement
Timeline
Clinical Trial Manager
IQVIA
06.2022 - Current
Senior Clinical Research Associate III
IQVIA
07.2019 - 06.2022
Senior Clinical Research Associate II
Syneos Health
01.2018 - 05.2019
Senior Clinical Research Associate
Inventiv Health
12.2015 - 12.2017
Clinical Research Associate
Inventiv Health
12.2013 - 11.2015
Master of Science - M.Sc. Public Health (MPH)
University of North Texas Health Science Center
Bachelor of Science - Earth & Environmental Sciences.
North Carolina A&T State University
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