Summary
Overview
Work History
Education
Skills
Clinical Monitoring Experience
Vendor Experience
System Experience
Timeline
Generic

Ola Tokunbo

Atlanta

Summary

Dynamic Senior Clinical Trial Manager with extensive experience at BNT Clinical, excelling in clinical trial oversight and vendor management. Proven track record in regulatory compliance and project management, fostering strong relationships with stakeholders. Adept at data analysis and leading teams, ensuring successful trial execution and adherence to timelines.

Overview

13
13
years of professional experience

Work History

Senior Clinical Trial Manager

BNT Clinical
01.2020 - Current
  • Manages all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG).
  • Assists in the development of case report forms (CRFs) and participates in EDC and IVRS specification process.
  • Manage the coordination of clinical trial milestones and ensure adherence to project timelines and budgets.
  • Responsible for providing oversight to the site management activities of phase I-IV clinical trials outsourced to a Contract Research Organization (CRO) from trial planning through End of Study, in compliance with SOPs, MP, ICH GCP and regulatory requirements.
  • Manage the clinical operations department procedures and ensure adherence to clinical operations department standards.
  • Contributes to and reviews country/site ICF customizations prepared by CRO and oversees timely ICF implementation on site level.
  • Reviews and approves CRO monitoring plan, monitoring visit report annotations and Investigator Site File templates prepared by CRO.
  • Performs co-monitoring visits with the CRO CRA in compliance with annual co-monitoring plan.
  • Provides governance on site-specific TMFs maintained by the CRO.
  • Participates in CTT meetings as a core member.

Clinical Trial Manager

Axios Clinical
10.2018 - 01.2020
  • Lead on a macro and micro level to ensure each team member understands roles and expectations.
  • Created detailed trackers/reports to ensure down to the site level all data is being tracked and escalations handled appropriately.
  • Planned investigator meetings and makes presentations, as required.
  • Prepared study-specific training materials, study reference binders, and subject diaries.
  • Reviewed clinical data at the CRF, data listing, and report table levels.
  • Managed project timelines and vendor performance.
  • Reviewed and approve Monitoring Plans.
  • Ensured the resolution/follow-up of site and vendor audit issues.
  • Resolved issues as a point of escalation for CRAs.
  • Built and maintain long-term professional relationships with clinical investigators.
  • Support CRAs with development of recruitment strategies and with resolution of significant site issues.
  • Engages and reports up and down the chain of command effectively.
  • Manages the day-to-day operations and execution of clinical trials to ensure the trial activities are conducted per ICH/GCP and regulatory compliance.
  • Serves as primary clinical operations contact managing protocol execution.
  • Plans and manages clinical trial(s) including participated in the selection of investigators and study sites.
  • Serves as a primary contact for the sites, responding to issues and recommending corrective actions, as well as discussing recruitment issues.

Senior Clinical Research Associate

Axios Clinical
10.2016 - 09.2018
  • Performed onsite Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities as assigned to ensure facilities are adequate, investigative site staff are adequately qualified and the site’s activities follow the clinical trial protocol and all applicable governmental and regulatory/ethics regulations.
  • Analyze monitoring metrics in support of proactive issue identification and continuous efficiency and monitoring performance improvement.
  • Assist in developing Protocols, SOPs, ICF and clinical monitoring tracking tools.
  • Conduct site evaluation, site initiation, monitoring and close-out visits as needed and conduct performance assessment of assigned CRA’s.
  • Contribute to organizational improvement within Clinical Operations and clinical monitoring in the execution of clinical trials.
  • Collaborate with Clinical Trial Leads (CTLs) in the implementation of clinical study plans as well as manage monitoring resources and resource projections across clinical trials to ensure milestones and deliverables are met.
  • Communicated with assigned clinical research investigators and staff on a regular basis, documenting the correspondence as per the study specific guidelines.
  • Reviewed regulatory documentation/file at the site for completeness, collects updated forms as applicable.
  • Trained investigative site staff as necessary.
  • Provided regular updates to project manager regarding the status of assigned sites (i.e., screening, enrolment, etc.).

Clinical Research Associate I & II

Axios Clinicals
04.2014 - 10.2016
  • Visited sites to assess the qualification of potential investigative sites, initiated studies, instructed site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies.
  • Monitored clinical trials to ensure sponsor and investigator obligations were met and compliant with applicable local regulatory requirements and ICH guidelines.
  • Provided regular clinical status information to team members and project management.
  • Performed billable work in accordance with company policies, procedures, and Standard Operating Procedures.
  • Worked closely with other team members to ensure timely resolution of project and/or clinical issues and obtained direction from more senior clinical operations staff.
  • Communicated common site trends to Lead CRA and other project team members.
  • Performed investigative site file reconciliation; requested any new or updated site-related essential and non-essential documents and reviewed them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements.
  • Performed source document verification, retrieved Case Report Forms (CRFs), performed query resolution in a timely manner and performed drug accountability and safety at investigative sites.
  • Ensured Serious Adverse Event (SAE) reporting according to project specifications.
  • Responded to requests from investigative sites in a timely fashion.
  • Mentored junior level CRAs and serves as a resource for new employees.

Clinical Research Coordinator

Emory University
Atlanta
08.2012 - 02.2014
  • Communicated professionally and timely with all relevant staff involved in the clinical research study.
  • Performed source data verification per contractual requirements.
  • Assures timely completion and submission of Case Report Forms per Clinical Monitoring Plan and/or Data Management Plan.
  • Completed and submits visit reports per SOP/Works Instructions (WI) requirements.
  • Maintains awareness of key study performance indicators for own sites, e.g., Telephone Communications Reports, patient enrollment, and SAEs.
  • Scheduled subjects in a timely manner to perform all screening procedures and test while staying within protocol allowed windows.
  • Followed informed consent processes and maintained records.
  • Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
  • Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
  • Assessed drug/study supply status and requested outstanding documents.
  • Followed-up on data entry, query status and SAEs.
  • Collected data and followed research protocols, operations manuals and case report form requirements.
  • Maintained compliance with protocols covering patient care and clinical trial operations.

Education

Associate of Science - Logistics and Supply Chain Management

Chattahoochee Technical College
Atlanta, CA

Bachelor of Science - Communication

Madonna University
Nigeria

Skills

  • Clinical trial management
  • Vendor management
  • Regulatory compliance
  • Project management
  • Data analysis
  • Case report forms
  • Clinical trial oversight
  • Regulatory submissions
  • Clinical operations
  • Informed consent process
  • Site monitoring
  • Good clinical practice
  • IRB and IEC submissions
  • Leadership skills
  • Trial oversight
  • Informed consent
  • Interpersonal skills
  • Multitasking capacity

Clinical Monitoring Experience

  • Cardiovascular, Heart Valves (Device), Phase III
  • Cardiovascular, Heart Failure, Phase II
  • Cardiovascular, Hypertension, Phase II
  • Respiratory, COPD, Phase III
  • Respiratory, Asthma, Phase III
  • CNS, Acute Pain, Phase II
  • CNS, Epilepsy, Phase II
  • Dermatology, Acne, Phase III
  • Dermatology, Eczema, Phase III
  • Nephrology, Nephrotic Syndrome, Phase I
  • Medical Device, Cardiac Pacemaker, Phase IV/PMS
  • Infectious Disease, Malaria, Phase I
  • Infectious Disease, TB, Phase I
  • Infectious Disease, Herpes (HSV), Phase I
  • Infectious Disease, HIV/Aids /COVID-19 Vaccine, Phase II/III
  • Infectious Disease, Hepatitis B, Phase II
  • Hepatology, NASH, Phase II

Vendor Experience

  • Inlingua
  • ICON Lab
  • Imperial
  • PCI Bridge
  • EPRO
  • Parexel (formally perceptive)
  • 4G clinicals

System Experience

  • Medidata Rave
  • Iconlab
  • Inform
  • Clinphone
  • RTSM
  • Cosmos
  • Impact
  • ETMF
  • IVRS
  • IWRS
  • Veeva Vault
  • Budco Dialogue Direct
  • Signant health TrialMax
  • HOT
  • Firecrest
  • Qliksense

Timeline

Senior Clinical Trial Manager

BNT Clinical
01.2020 - Current

Clinical Trial Manager

Axios Clinical
10.2018 - 01.2020

Senior Clinical Research Associate

Axios Clinical
10.2016 - 09.2018

Clinical Research Associate I & II

Axios Clinicals
04.2014 - 10.2016

Clinical Research Coordinator

Emory University
08.2012 - 02.2014

Associate of Science - Logistics and Supply Chain Management

Chattahoochee Technical College

Bachelor of Science - Communication

Madonna University

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Ola Tokunbo