Clinical Trial Manager
Open To Work
ELFRIDA AGBAMUCHE
PHARPOINT RESEARCH
Charlotte,NC
Work Preference
Job Search Status:
Open to work
Desired Job Title
Clinical Trial Manager
Work Type
Full TimePart Time
Location Preference
RemoteHybrid
Location:
Charlotte, NC
Open to relocation:
No
Minimum Desired Compensation
100000/yr
Important To Me
Flexible work hoursCareer advancement
11
years of professional experience
Results-driven Clinical Trial Manager and Clinical Research Professional with 10+ years of progressive CRO experience, advancing from In-House Clinical Research Associate to Clinical Trial Manager. Extensive experience supporting Phase I–IV clinical trials across pharmaceutical, biotechnology, medical device, cardiovascular, CNS, infectious disease, and vaccine programs. Expertise in clinical trial execution, site management, monitoring oversight, study start-up, risk mitigation, vendor coordination, clinical documentation, and cross-functional leadership. Proven ability to partner with Sponsors, Principal Investigators, study coordinators, medical monitors, data management, regulatory, and clinical operations teams to deliver high-quality studies in compliance with ICH-GCP, FDA regulations, applicable international requirements, and sponsor SOPs.
Work History
CLINICAL TRIAL MANAGER
1 Year 7 Months- Provide clinical operational leadership and oversight for assigned Phase I–IV clinical trials from study start-up through closeout.
- Serve as a primary clinical operations contact for Sponsors, investigators, CRAs, vendors, and cross-functional study teams.
- Develop and maintain study plans, timelines, milestones, enrollment strategies, monitoring plans, and operational deliverables.
- Lead cross-functional teams and align Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Regulatory, Safety, and vendors.
- Identify study risks and operational challenges; develop proactive mitigation and contingency strategies to protect quality and timelines.
- Oversee CRA performance and monitoring activities, including visit completion, follow-up, action items, issue escalation, and site performance.
- Review study metrics, enrollment, deviations, monitoring reports, data issues, and site performance to identify trends requiring intervention.
- Maintain investigator/site relationships and support resolution of operational, regulatory, enrollment, and protocol-related challenges.
- Oversee TMF/eTMF completeness and inspection readiness; support study meetings, sponsor communications, and study closeout.
- Clinical Research Organization (CRO)
SENIOR CLINICAL RESEARCH ASSOCIATE
2 Years 11 Months- Served as a senior clinical monitoring resource responsible for assigned clinical trial sites across Phase I–IV studies.
- Conducted and/or oversaw Site Initiation Visits, Interim Monitoring Visits, remote monitoring, and Close-Out Visits in accordance with monitoring plans.
- Maintained strong relationships with Principal Investigators, pharmacists, research coordinators, and site personnel to facilitate successful trial execution.
- Monitored sites for protocol, ICH-GCP, FDA, applicable regulatory, and Sponsor/CRO SOP compliance.
- Performed source data review/verification, informed consent review, investigational product accountability, essential document review, and protocol compliance assessments.
- Identified deviations, data discrepancies, enrollment issues, and site performance concerns; supported corrective and preventive actions.
- Mentored junior CRAs and supported study-level tracking, metrics, enrollment oversight, risk assessment, and operational planning.
- Collaborated with Project Managers, Medical Monitors, Data Management, Safety, and Regulatory teams to resolve study issues and maintain inspection readiness.
- Clinical Research Organization (CRO)
CLINICAL RESEARCH ASSOCIATE
2 Years 11 Months- Conducted routine and targeted monitoring activities for assigned sites across Phase I–IV clinical trials, including SIVs, IMVs, remote monitoring, and COVs.
- Verified informed consent, source documentation, eligibility criteria, protocol compliance, investigational product accountability, and safety reporting requirements.
- Built productive relationships with Principal Investigators, research coordinators, pharmacists, and site staff.
- Monitored recruitment, enrollment, retention, protocol deviations, and site performance against study expectations.
- Prepared monitoring reports and followed up on outstanding action items within required timelines.
- Supported site activation and closeout, essential document collection, TMF/eTMF maintenance, and cross-functional study execution.
- Clinical Research Organization (CRO)
IN-HOUSE CLINICAL RESEARCH ASSOCIATE
3 Years 1 Month- Provided clinical operations support to CRAs and study teams across assigned clinical trials.
- Supported site management, study start-up, monitoring preparation, study documentation, and tracking of clinical trial deliverables.
- Reviewed clinical trial documentation for completeness, accuracy, and compliance with study requirements.
- Assisted with TMF/eTMF filing and reconciliation to support complete, accurate, and inspection-ready study documentation.
- Communicated with clinical sites regarding outstanding documents, data queries, action items, and study requirements.
- Supported monitoring report preparation, follow-up activities, study metrics, enrollment reporting, and issue escalation.
- Clinical Research Organization (CRO)
Education
PhD - Law
Master Of Laws(LL.M)
Bachelor of Laws (LL.B.)
Skills
Clinical Trial Management
Clinical Operations
Phase I–IV Trials
Study Start-Up
Site Activation
Site Management
SIV / IMV / COV
Risk-Based Monitoring
Protocol Compliance
Investigator Relationships
Vendor Management
Cross-Functional Leadership
Study Timelines & Milestones
Enrollment & Retention
Risk & Issue Management
CAPA
Regulatory Compliance
Audit/Inspection Readiness
TMF/eTMF
Data Review
Protocol Deviations
Safety Reporting
Sponsor Communication
ICH-GCP
FDA Compliance
ALCOA-C+
ICH-GCP / ICH E6
FDA Regulations
ISO 14155
ISO 20916
MDR/IVDR
GDPR
CLSI
ALCOA-C+ Data Integrity
Sponsor SOPs
Audit Readiness
Inspection Readiness
TMF/eTMF Compliance
Medical Devices
Cardiovascular
CNS/Neurology
Infectious Disease
Vaccines
Pharmaceutical
Biotechnology
Medidata Rave
Veeva
CTMS
EDC
ETMF
Epic / EMR
Microsoft Office Suite
Clinical Trial Management Systems
Websites
Regulatory Quality Expertise
- ICH-GCP / ICH E6
- FDA Regulations
- ISO 14155
- ISO 20916
- MDR/IVDR
- GDPR
- CLSI
- ALCOA-C+ Data Integrity
- Sponsor SOPs
- Audit Readiness
- Inspection Readiness
- TMF/eTMF Compliance
Therapeutic Experience
- Medical Devices
- Cardiovascular
- CNS/Neurology
- Infectious Disease
- Vaccines
- Pharmaceutical
- Biotechnology
Timeline
CLINICAL TRIAL MANAGER
PHARPOINT RESEARCH
02.2025 - CurrentRead More
SENIOR CLINICAL RESEARCH ASSOCIATE
PHARPOINT RESEARCH
03.2022 - 02.2025Read More
CLINICAL RESEARCH ASSOCIATE
PHARPOINT RESEARCH
04.2019 - 03.2022Read More
IN-HOUSE CLINICAL RESEARCH ASSOCIATE
PHARPOINT RESEARCH
03.2016 - 04.2019Read More
University of Leeds
PhD from Law
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Ahmadu Bello University
Bachelor of Laws (LL.B.)
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University of Leeds
Master Of Laws(LL.M)
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