Summary
Overview
Work History
Education
Skills
System Experience
Vendor Experience
Therapeutic Expertise
Personal Information
Languages
Timeline
Generic

TOM-EZEWU OGHENEKEVBE

Saskatoon,Canada

Summary

Highly qualified Clinical Trial Lead with vast experience in leading the planning, implementation and execution of study protocols, operational plans, and study timelines in alignment with study goals. Knowledgeable in study monitoring of all phases of clinical trials (Phase I – Phase IV) to ensure the safety of human subjects and verify clinical data credibility. Possesses strong project management skills with adept knowledge of ISO, ICH, GCP FDA and other relevant study guidelines.

Overview

14
14
years of professional experience

Work History

Clinical Trial Lead

VIAL CRO
02.2020 - Current
  • Manage clinical operations deliverables including timeline, quality, scope, and financials
  • Work closely with the Project Manager to develop plans, monitor resource allocation, and ensure that clinical site management and monitoring is being delivered per contract with quality and efficiency
  • Proactively identify risks and escalate to Project Manager and other appropriate functional leads
  • Develop and maintain project-specific clinical operations plans as required per project (e.g., Clinical Monitoring Plan, Cohort Management Plan, Recruitment Plan, etc.) Develop and maintain project-specific clinical operations reference materials and tools, including study-specific forms and logs
  • Develop training materials and conduct training for the clinical operations team throughout the project lifecycle
  • Provide operational oversight for site and CRA deliverables and key performance indicators such as site activation, subject recruitment, site monitoring visits, data currency, and quality
  • Manage CRA resourcing, site assignments, visit schedules and serve as the initial point of contact for clinical operations and monitoring issues
  • Review and approve site monitoring visit reports; monitor and track related metrics for compliance with Clinical Monitoring Plan and SOPs
  • Conduct monitoring visits, co-monitoring visits, assessment visits, and/or team training as necessary
  • Ensure quality of the trial master file through content (QC) review of document packages submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted
  • Assist Clinical Project Lead by tracking compliance to all study level plans and escalating any variances.

Senior Clinical Research Associate

VIAL CRO
02.2016 - 01.2020
  • Conducted clinical monitoring duties including qualification, initiation, interim and close out visits both on-site and remotely
  • Followed and ensured assigned studies were conducted in compliance with the approved Protocol(s)/Amendment(s), Standard Operating Procedures (Advanced Clinical or Sponsor SOPs), Code of Federal Regulations (CFR), Good Clinical Practice (ICH GCP), and local or country regulations
  • Participated in Investigator feasibility and selection process by contacting sites to obtain feasibility information
  • Conducted site qualification (pre-study), site initiation, routine interim and close-monitoring visits for assigned studies and sites
  • Travelled to research sites to conduct on-site visits as required
  • Prepared site submissions to the Independent Ethics Committees (central and local) and to Competent/Regulatory Authorities, when applicable
  • Assisted with the development of Investigator and Institution contracts and budget templates, negotiates site budgets, and arranges site payments, when applicable
  • Attended internal CRA Team meetings and participated in study team and sponsor meetings, as required
  • Participated in Investigator meetings and assisted with meeting preparation, when required
  • Conducted monitoring visits per the monitoring visit frequency defined in the Monitoring Plan or as instructed by the study team and confirmed visit attendance by sending visit confirmation letters to site staff
  • Managed my own monitoring visit schedule for all assigned sites in accordance to the Monitoring Plan or the study needs
  • Proactively scheduled appointments to meet with site staff during monitoring visits
  • Verified that all delegated study staff at assigned sites were trained/certified and maintained compliance with requirements of the study protocol, informed consent process, data collection requirements, Investigational Product/Investigational Medical Device (IP/IMP) accountability/supply management, and safety reporting requirements.

Clinical Research Associate

PREMIER RESEARCH
08.2013 - 01.2016
  • Performed monitoring activities (both on-site and remote) for Phase I-IV clinical trials, as well as device trials while working in therapeutic areas such as: cardiovascular, oncology, pediatrics, rare disease, women’s health, dermatology, neurology, etc
  • Ensured the validity, correctness, and completeness of clinical data collected at sites with a focus on data integrity and patient safety as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements
  • Served as the primary point of contact for investigative sites, managed query resolution, supported Trial Master File activities, participated in Investigators’ Meetings, and completed other project tasks in accordance with study timelines and budget
  • Identified and escalated potential risks and possible retraining opportunities for investigative sites
  • Scheduled and planned day-to-day activities including study monitoring visits, timely completion of high-quality trip reports, and active management of all deliverables
  • Performed SDV, retrieved CRFs, performed query resolution in a timely manner, and oversaw drug accountability and safety at investigative sites
  • Ensured SAE reporting according to project specifications, reviewed SAE information, resolved queries, and assisted sites in the completion of SAE reports.

Clinical Trial Assistant

ICON
04.2010 - 07.2013
  • Assisted Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines
  • Assisted the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
  • Assisted with periodic review of study files for completeness
  • Assisted CRAs with the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
  • Assisted with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
  • Acted as a central contact for the clinical team for designated project communications, correspondence and associated documentation
  • Occasionally accompanied CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Education

Bachelor of Pharmacy (B.Pharm) -

University of Benin
01.2001

Skills

  • Trial Oversight
  • Site Investigation Reports
  • Clinical Trials and Research
  • Archival Processing
  • Research Protocols
  • Chorionic Villus Sampling

System Experience

  • Medidata Rave
  • Datalab
  • Medrio
  • Inform
  • Bioclinica
  • PhlexEview
  • Seibel (CTMS)
  • IMedidata CTMS
  • Impact Harmony
  • ETMF
  • IVRS
  • IWRS
  • Suvoda
  • ERT
  • Veeva Vault
  • Veracity Logic
  • SharePoint

Vendor Experience

  • Suvoda
  • Endpoint
  • Q2 Lab
  • BARC
  • ERT
  • Oracle IRT
  • PPD Lab
  • PRA Lab
  • Covance Lab
  • Novotech

Therapeutic Expertise

  • Cardiovascular: Hypertension, Stroke, Cardiac Failure
  • Infectious Disease: HIV
  • Central Nervous System: Parkinson’s, Schizophrenia
  • Medical Device
  • Endocrinology: Diabetes
  • Vaccine: COVID- 19, HPV
  • Oncology: Ovarian, Breast& Lung Cancer
  • Dermatology: Atopic Dermatitis

Personal Information

Title: CLINICAL TRIAL LEAD

Languages

English
Full Professional

Timeline

Clinical Trial Lead

VIAL CRO
02.2020 - Current

Senior Clinical Research Associate

VIAL CRO
02.2016 - 01.2020

Clinical Research Associate

PREMIER RESEARCH
08.2013 - 01.2016

Clinical Trial Assistant

ICON
04.2010 - 07.2013

Bachelor of Pharmacy (B.Pharm) -

University of Benin

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TOM-EZEWU OGHENEKEVBE