Bryant Moore
Cypress,Tx
Summary
Experienced Clinical Research Project Manager with over 14 years of expertise in Phase I-III clinical trials across Oncology, Infectious Diseases, and CNS disorders. Strong background in Clinical Trial Management (3+ years), monitoring (7+ years), and government-funded clinical research. Proven ability to lead cross-functional teams, manage budgets, oversee eTMF compliance, and ensure adherence to GCP, ICH, and FDA regulations. Extensive experience with EDC, CTMS, and IVRS systems. Adept at navigating the unique policies and requirements of government-sponsored trials.
Overview
13
13
years of professional experience
Work History
Project Manager
ICON Government and Public Health Solutions
01.2023 - Current
- Serve as primary liaison with clients, managing contractual, organizational, and relationship needs while ensuring alignment with expectations.
- Lead cross-functional teams, vendors, and stakeholders, optimizing resource utilization and project performance.
- Oversee project deliverables, financials, and risk management, proactively addressing challenges, ensuring budget adherence, and mitigating potential overruns.
- Monitor project progress and key metrics, driving compliance with company SOPs, policies, and contractual agreements.
- Manage invoicing, investigator payments, and revenue projections, ensuring financial efficiency and accountability.
- Provide leadership, mentorship, and strategic guidance, supporting teams in troubleshooting, contingency planning, and performance optimization.
Senior Clinical Trial Manager
ICON Government and Public Health Solutions
01.2023 - 12.2023
- Plan, schedule, and execute clinical project activities in alignment with contract and budget, ensuring compliance with protocols, amendments, and regulatory requirements.
- Monitor key clinical metrics (e.g., Days on Site (DOS), Monitoring Visit Reports (MVRs), Follow-Up Letters (FULs), and Action Items (AIs)), ensuring timely completion and issue resolution.
- Develop and maintain clinical project plans, integrating all operational elements, including protocol implementation, deviation tracking, IP management, and investigator payments.
- Create and oversee operational plans for clinical deliverables, including CRF completion guidelines, Monitoring Plans, Recruitment Strategies, and Clinical Training Programs.
Clinical Trial Manager
ICON Government and Public Health Solutions
01.2021 - 12.2023
- Developed training materials for site staff to enhance their understanding of the study protocol, resulting in improved adherence to requirements.
- Streamlined trial management processes for increased efficiency through diligent organization and coordination of resources.
- Plan, schedule and implement the clinical aspects of projects in line with contract and budget, e.g. implementation of protocol and amendments; protocol deviation prevention,
tracking and reporting; IP management, timely investigator payments. - Oversee key clinical metrics including but not limited to: Days on Site (DOS), Monitoring Visit Report (MVR) and Follow up Letters (FUL) timelines, Action Items (AI) and other quality metrics, to ensure they are met and followed-up as necessary.
- Contribute to the development and maintenance of all clinical elements of cross functional project plans.
- Develop and maintain operational plans for clinical deliverables e.g., CRF completion guideline,
Monitoring Plan, Recruitment Plan, Clinical Training Plan, annotated trip report etc.
Senior Clinical Research Associate
ICON Government and Public Health Solutions
08.2020 - 12.2021
- Conducted comprehensive site monitoring and regulatory audits to ensure full compliance with FDA regulations and government-sponsored research guidelines.
- Trained, mentored, and supervised Clinical Research Associates (CRAs), ensuring adherence to best practices and regulatory standards.
- Supported Clinical Project Managers in project coordination, planning, and logistics, including budget oversight and timeline management.
- Facilitated risk mitigation strategies, ensuring timely resolution of action items and implementation of Corrective and Preventative Action Plans (CAPA).
- Led site feasibility assessments, including questionnaire development, site outreach, and qualification reviews to select high-performing research sites.
- Provided daily oversight of CRAs, conducting co-monitoring visits for quality assessment and training.
- Developed and implemented clinical monitoring plans, contributing to the creation of essential study documents such as Safety Monitoring Plans, Manuals of Operations, and Informed Consent Forms.
- Reviewed and approved monitoring reports and follow-up communications, ensuring consistency, accuracy, and regulatory adherence.
- Managed clinical trial sites, ensuring protocol compliance, GCP/ICH adherence, and alignment with applicable regulations.
- Conducted key monitoring visits (including Site Qualification, Site Initiation, Interim Monitoring, Close-out, and Audit Preparation), ensuring site readiness and regulatory compliance.
Senior Clinical Research Associate
PRA Health Sciences
01.2018 - 08.2020
- Conducted site initiation, monitoring, and closeout visits, ensuring adherence to study protocols, regulatory requirements, and data integrity standards while maintaining oversight of investigational sites.
- Managed project risk and data quality by identifying potential issues, reviewing source data, case report forms (CRFs), and consent documentation, and resolving discrepancies to support accurate study outcomes.
- Provided ongoing communication and support to investigators, site coordinators, sponsors, and clinical teams, ensuring smooth trial operations and compliance with Good Clinical Practice (GCP) and regulatory guidelines.
- Trained and supervised site personnel, covering therapeutic areas, protocol requirements, and proper documentation procedures while ensuring timely and accurate data entry.
- Oversaw Trial Master File (TMF) management, regulatory documentation, and investigational product logistics, ensuring audit readiness and compliance with industry standards.
Clinical Research Associate II
Parexel
01.2015 - 12.2018
- Performed initiation, monitoring, and closeout visits to verify compliance with study procedures, regulatory requirements, and data integrity.
- Communicated project status to clinical management through verbal updates, technical reports, and presentations.
- Identified, assessed, and mitigated project risks, ensuring proactive issue resolution and regulatory compliance.
- Reviewed participant eligibility and consent documentation, supporting data accuracy and protocol adherence.
- Maintained strong collaboration with study centers, investigators, coordinators, and sponsors, facilitating smooth trial operations.
- Verified source data and case report forms (CRFs) for accuracy and completeness, resolving discrepancies to maintain data integrity.
- Trained and supported site personnel on therapeutic areas, protocol requirements, and documentation best practices.
- Managed investigational product logistics, including preparation, shipment, tracking, and returns.
- Maintained and audited study documentation, ensuring compliance within the Trial Master File (TMF) for regulatory readiness.
Clinical Research Associate I/II
Medpace
01.2013 - 12.2015
- Performed initiation, monitoring, and closeout visits to verify compliance with study procedures, regulatory requirements, and data integrity.
- Communicated project status to clinical management through verbal updates, technical reports, and presentations.
- Identified, assessed, and mitigated project risks, ensuring proactive issue resolution and regulatory compliance.
- Reviewed participant eligibility and consent documentation, supporting data accuracy and protocol adherence.
- Maintained strong collaboration with study centers, investigators, coordinators, and sponsors, facilitating smooth trial operations.
- Verified source data and case report forms (CRFs) for accuracy and completeness, resolving discrepancies to maintain data integrity.
- Trained and supported site personnel on therapeutic areas, protocol requirements, and documentation best practices.
- Managed investigational product logistics, including preparation, shipment, tracking, and returns.
- Maintained and audited study documentation, ensuring compliance within the Trial Master File (TMF) for regulatory readiness.
Clinical Research Associate I
Covance
01.2012 - 12.2013
- Performed initiation, monitoring, and closeout visits to verify compliance with study procedures, regulatory requirements, and data integrity.
- Communicated project status to clinical management through verbal updates, technical reports, and presentations.
- Identified, assessed, and mitigated project risks, ensuring proactive issue resolution and regulatory compliance.
- Reviewed participant eligibility and consent documentation, supporting data accuracy and protocol adherence.
- Maintained strong collaboration with study centers, investigators, coordinators, and sponsors, facilitating smooth trial operations.
- Verified source data and case report forms (CRFs) for accuracy and completeness, resolving discrepancies to maintain data integrity.
- Trained and supported site personnel on therapeutic areas, protocol requirements, and documentation best practices.
- Managed investigational product logistics, including preparation, shipment, tracking, and returns.
- Maintained and audited study documentation, ensuring compliance within the Trial Master File (TMF) for regulatory readiness.
Education
Bachelor of Science - History
Northern Illinois University
DeKalb, IL12-2010
Websites
Technical Skills And Certifications
- Clinical Trial Management Systems (CTMS): Medidata, Oracle, Veeva Vault
- Electronic Data Capture (EDC): Rave, Inform, Medrio
- Regulatory Compliance: GCP, ICH, FDA, NIH, and government-sponsored trial policies
- Project & Risk Management: Budget oversight, cross-functional leadership, risk mitigation
Therapeutic Area Research Experience
Oncology: Breast, Multiple Myeloma, Lung, Prostate, Ovarian Cancer (Phases I-III)
Infectious Disease: COVID-19, HIV, Anthrax, Gonorrhea, Chlamydia (Phases II-III)
CNS Disorders: Epilepsy, Bipolar Disorder, Alzheimer's Disease (Phases II-III)
Government Funded Clinical Trial Experience
Expert in government-funded trials, including BARDA and GARDP-sponsored studies, which require additional regulatory oversight, specialized reporting, and adherence to federal compliance frameworks. Experience includes managing IND submissions, contractual obligations, and coordinating with government regulatory bodies.
Protocols Managed
Sponsor: Inovio Pharmaceuticals
- Study: INO-4800 Vaccine Trial for Efficacy (Phase II/III)
- Protocol:COVID19-311
- Description: Multinational trial evaluating INO-4800’s immunogenicity, safety, and efficacy against SARS-CoV-2.
Sponsor: Novavax
- Study: NVX-CoV2373 (2019nCoV-301) (Phase III)
- Protocol: 2019nCoV-301
- Description:** Large-scale study testing protein-based vaccine, comparing efficacy across diverse global populations.
Sponsor: BARDA
- Study: Anthrax AV7909 Boost Evaluation (ABEST) (Phase II)
- Protocol: ABST001
- Description: Evaluating the safety and immune response of AV7909, a next-generation anthrax vaccine.
Sponsor: BARDA
- Study: H5N8 Influenza Vaccine
- Protocol: BP-I-23-001
- Description: Testing a novel influenza vaccine against H5N8 avian flu, evaluating immune response and pandemic preparedness.
Sponsor: GARDP
- Study: Zoliflodacin in Uncomplicated Gonorrhea (Phase III)
- Protocol: STI_Zoli001
- Description: Investigating Zoliflodacin, a new oral antibiotic for drug-resistant gonorrhea.
Timeline
Project Manager
ICON Government and Public Health Solutions
01.2023 - Current
Senior Clinical Trial Manager
ICON Government and Public Health Solutions
01.2023 - 12.2023
Clinical Trial Manager
ICON Government and Public Health Solutions
01.2021 - 12.2023
Senior Clinical Research Associate
ICON Government and Public Health Solutions
08.2020 - 12.2021
Senior Clinical Research Associate
PRA Health Sciences
01.2018 - 08.2020
Clinical Research Associate II
Parexel
01.2015 - 12.2018
Clinical Research Associate I/II
Medpace
01.2013 - 12.2015
Clinical Research Associate I
Covance
01.2012 - 12.2013
Bachelor of Science - History
Northern Illinois University
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