Summary
Overview
Work History
Education
Skills
Certification
Residency
Volunteer Experience Membership
Therapeutic Areas
Languages
References
Timeline
Generic

Glory Buzugbe

Summary

Experienced Clinical Research professional with over 7 years’ experience of comprehensive knowledge in Clinical Trial processes - Site Monitoring, Site Selection and Site Management procedures. Exceedingly proficient in the implementation and initiation of Clinical process improvements alongside identifies operational problems to minimize project delays to increase departmental efficiency. Proven ability to manage multiple projects simultaneously from initiation to study close out.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Clinical Project Manager

BAXTER
08.2023 - Current
  • Drives and owns the overall delivery of assigned clinical projects within the Healthcare Systems & Technology Department at Baxter
  • Conduct clinical site monitoring visits across protocols and multiple therapeutic areas Conduct site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Standard Operating Procedures (SOPs) and business processes Prepares clinical plans that meet product design goals, intended use, regulatory requirements, divisional operating procedures, and Clinical Research work instructions
  • Collaborated with cross-functional PMOs in Quality, Clinical, Operations, and Finance to develop and implement process to assist project and functional management in accurate and aligned annual operating resource planning for all funded projects
  • Participate in field training and mentoring of new/junior CRAs as well as insource CRAs
  • Proactively identify issues that may impact enrollment and recruitment timelines and provide objective comments regarding these issues
  • Identified and resolve operational problems and minimize delays
  • Identify, evaluate, and implement process improvements within the clinical operations and clinical affairs organization
  • Prepares clinical protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies Proposes and negotiates budgets for clinical studies and initiates payments to clinical sites and vendors
  • Collaborate with Clinical Operations to develop Investigator agreements, site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures Monitors clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines
  • Leads several cross functional meetings such as data review meetings, Quarterly compliance meetings, Field Actions, and subject eligibility committee meetings (SEC) Prepares and presents project progress reports to management and team
  • Prepares clinical sections of regulatory submissions and international registration packages
  • Assists Regulatory in preparing responses to regulatory agencies’ questions regarding the clinical study Participates in interviewing and hiring job candidates alongside directs, advises, trains, mentor and educate CRAs/ Site Managers/ project analyst to departmental procedures
  • Suggests improvements for increased departmental efficiency.

Sr. Clinical Research Associate (CRA)

ICON Plc.
07.2021 - 08.2023
  • Performed investigation on clinical trials and medical devices
  • Monitored clinical trials according to FDA requirements and regulations
  • Evaluate investigational sites and ensure maintenance of data integrity
  • Managed investigator agreements and obtained required approvals
  • Trained staff for clinical trials for various investigational devices
  • Assisted in the development of clinical protocols and prepared case report forms and manuals
  • Prepared clinical data summaries for FDA regulations
  • Assisted to resolve all data queries for customers
  • Audited CRO's monitoring at the sites
  • Reviewed and approved CRF's and source documents
  • Ensured data quality and compliance by routinely participating in co-monitoring activities and mentoring CRAs and study team members assigned to a specific project
  • Recognized for effectively managing study budget and timeline commitments
  • Presented to investigators and clinical staff to ensure proper training and understanding of the clinical trial process and protocol
  • Ensure all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations
  • Review and approve critical document packages
  • Monitors study progress and routinely interacts with study teams and management to inform them of issues that may impact study milestones
  • Assures subject rights, safety, and welfare are protected; ensures data integrity through completeness, accuracy, and legibility
  • Conducted site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Standard Operating Procedures (SOPs) and business processes.

Clinical Research Specialist (CRS)/ CRA

MEDTONIC INC
Mounds View
07.2017 - 07.2021
  • Acted as a central contact for the clinical team for designated project communications, correspondence, and associated documentation
  • Performed responsibilities in accordance with Standard Operating Procedures, Oversaw clinical study including enrolment, long-term follow-up, trial master file maintenance and study activation phases
  • Prepared IRB submissions for studies using central IRBs
  • Performed site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, the company’s standards, guidelines, and policies, and writing of monitoring visit reports
  • Prepared site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan.

Education

BSc. Economics -

COVENANT UNIVERSITY

Skills

  • Coordinating Site Operations
  • Workflow Efficiency
  • Clinical Operations Planning
  • Care Plan Discussion
  • Resource Coordination
  • Training And Mentoring
  • New Staff Mentoring
  • Coaching And Training
  • Improving Facility Workflows
  • Meeting Coordination
  • Inquiry Resolutions
  • Improving Clinical Quality Outcomes

Certification

  • PMI Certified Project Management Professional, 2022
  • NIDA ICH- GCP Certificate
  • NIH- Protecting Human Research Participants Certificate
  • Good Documentation Practices for Clinical Research Professionals
  • Good Manufacturing Practices for Clinical Research Professionals
  • Good Laboratory Practices for Clinical Research Professionals
  • Software Competency: Adobe, Windchill, Bracket, Veeva vault, MS Office, DataLab, Medidata rave, Omnicomm TrialMaster, Bioclinica, Pioneer (CTMS), Oracle-Seibel (CTMS) , IMPACT (CTMS)

Residency

USA Citizen

Volunteer Experience Membership

  • PMI Project Management Professional (PMP) – Membership Ambassador, 2022 – Present
  • StepUp Program Volunteer – empowering Minneapolis-area teens and young adults to get jobs.

Therapeutic Areas

  • Cardiovascular – Heart Valves, Mitral valve, cardiomyopathy, Atrial Fib., Arrhythmias, Heart disease, Heart Failure.
  • Respiratory — Asthma (Phase 2), COPD (Phase 2), COVID-19 (Phase 2 Infectious Disease)
  • Respiratory / Infectious Diseases - COVID-19 (Specimen Collection), COVID-19 (Phase 3)
  • Phases: II, III and IV.
  • Global/Regional Scope: North America, Latin America, Europe, and APAC

Languages

Fluent in English

References

REFERENCES AVAILABLE UPON REQUEST

Timeline

Clinical Project Manager

BAXTER
08.2023 - Current

Sr. Clinical Research Associate (CRA)

ICON Plc.
07.2021 - 08.2023

Clinical Research Specialist (CRS)/ CRA

MEDTONIC INC
07.2017 - 07.2021

BSc. Economics -

COVENANT UNIVERSITY

Similar Profiles

CREATE PROFILE
Glory Buzugbe