Summary
Overview
Work History
Education
Skills
Therapeutic Areas
Certification
Vendor System
Timeline
Generic

Oluwatomi Ojo

Houston,United States

Summary

Experienced Clinical Study Manager with expertise in overseeing end-to-end clinical study operations, ensuring timely, cost-effective, and high-quality delivery. Skilled in vendor and country management, study documentation, and eTMF oversight to maintain inspection readiness. Proven ability to resolve risks, manage budgets, and lead cross-functional teams while mentoring junior staff to optimize study efficiency.

Overview

15
15
years of professional experience
1
1
Certification

Work History

Clinical Trial Manager

AbbVie
Houston, TX
02.2018 - Current
  • Served as clinical lead in the implementation and execution of CRO specific operational plans according to Sponsor needs.
  • Led cross-functional study teams and external vendors.
  • Collaborated with key stakeholders and reported study progress to senior management.
  • Oversaw trial feasibility, site selection, and study start-up.
  • Prepared for quality assurance audits and inspections.
  • Managed study budgets and resources.
  • Created and presented the clinical operations section of the bid defense to display the clinical management and monitoring process for successfully running a clinical trial.
  • Contributed to the development of work instructions and SOPs.
  • Served as Site Management(SM) primary point of contact for clinical monitoring and site activities with the project.
  • Assisted with monitoring plans, literature review and protocol development, IRB submissions.
  • Supported CRAs, sites, and third-party vendors: developed and conducted training, led clinical team meetings, supported compliance and audits, conducted performance reviews.
  • Maintained timely and effective communication, and good working relationships, with investigative sites and study team to ensure effective and timely site start up.
  • Supported in planning and conducting Investigator Meetings.
  • Collaborated with PM on monthly invoicing and variance management of clinical budget
  • Conducted site visits and ensured compliance with protocols and regulations.
  • Maintained trial master files and monitored data quality.
  • Supported recruitment and retention strategies.
  • Prepared for audits and maintained documentation.
  • Primary clinical point of contact with the client.
  • Generated potential site list from key stakeholders and drive site feasibility process.
  • Developed and finalized the country recruitment/retention strategy.
  • Identified potential risks to the enrollment targets based on feasibility analysis and site's contracted commitment
  • Developed timely effective communication and good working relationships with investigative sites and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures.
  • Led internal clinical team meetings and set expectations for clinical team of CRAs and CTAs
  • Addressed all CRA and site questions and documented via the Frequently Asked Question (FAQ) log as appropriate.

Senior Clinical Research Associate

Syneos
Houston, TX
05.2014 - 01.2018
  • Conducts initiation, monitoring, and closeout visits to verify study procedures, regulatory documents, and data completion.
  • Assists project management with the development of study tools, presentations, and materials for the Investigator Meetings, Site Qualification Visits, and Site Initiation Visits, as required.
  • Coordinates and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance, and data quality.
  • Collaborates with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues. Participated in developing study plans and system set-up; participated in preparation and ensure operational excellence of protocol, CRF, CSR, and other key study team deliverables.
  • Implemented appropriate systems, standards and
    processes to ensure quality at the level of investigative
    sites, vendors and data; maintained clinical study files
    per ICH guidance.
  • Participated in preparation of vendor requirements
    and project scope and selection of study vendors; effectively managed interactions with vendor study
    team.
  • Created and conducted training sessions including
    investigator meetings and team trainings.
  • Performs remote site management/communication required between site visits (point of contact for site questions, query resolution and follow up to outstanding site actions).
  • Monitors clinical trials according to monitoring plans to achieve project goals; conducts or assists with site evaluations, study initiations, routine monitoring, site close-outs, and FDA audit preparations. Develops territory to broaden selection of research study sites.
  • Effectively communicates with site study staff and clinical research personnel to report study site status, disseminate information to the appropriate individuals, and resolve study-related issues; replies to audit findings.
  • Partners with assigned clinical project team. Assists with Investigator Meetings planning/presentations, data collection, and FDA submission preparations.
  • Manages work activities in a time and cost effective manner to ensure budgetary guidelines and project timelines are met.
  • Participates in internal and/or external meetings to maintain current knowledge on applicable regulations and guidelines.
  • Works closely with the extended study team including the Sponsor, Vendors, Data Manager(s), Statistician, Medical Monitor and other trial staff.
  • Performs all visit types according to the monitoring plan.
  • Maintained current and accurate protocol documentation; notified investigators of pertinent protocol changes.
  • Collaborated with sponsors on developing project timelines, budgets and milestones.
  • Maintained and completed regulatory documents for IRB.
  • Compiled and submitted data on appropriate forms, according to protocol requirements.
  • Collected and delivered specimens for analysis, using appropriate or specified equipment for collecting and handling specimens; ensured proper labeling and obtained pertinent clinical and protocol information on request forms; developed and maintained knowledge of various aspects of processing specimens, paying particular attention to safety practices.

Clinical Research Associate I & II

PRA Health Sciences
Houston, TX
01.2012 - 05.2014
  • Assisted Senior CRAs with on-site tasks as
    required and according to training goals (e.g. review
    of Case Report Forms and Study File Notebook, drug
    accountability).
  • Initiated, monitored and closed out clinical
    investigative sites, with or without direct supervision
    from Senior Clinical Research Associates, Clinical Team Leads, Project Managers or Project Directors, as
    assigned based on training status and adequate skillset acquisition.
  • Ensured the study staff who conducted the protocol
    received the proper materials and instructions to
    safely enter patients into the study.
  • Ensured the protection of study patients by verifying
    that informed consent procedures and protocol
    requirements were adhered to according to the
    applicable regulatory requirements.
  • Ensured the integrity of the data submitted on Case
    Report Forms (CRFs) or other data collection tools by
    careful source document review.
  • Monitored data for missing or implausible data.
  • Ensured the resources of the Sponsor and Icon were
    spent wisely by performing the required monitoring
    tasks in an efficient manner, according to SOPs and established guidelines, including managing travel
    expenses in an economical fashion according to Icon's travel policy.
  • Communicated with vendors to deliver appropriate clinical supplies to key areas and meet ongoing operational demands.
  • Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
  • Coordinated clinical study timelines with Project management to meet critical milestones; escalated issues that may jeopardize timelines and deliverables.
  • Provided monitoring oversight by reviewing monitoring schedules, metrics and reports. oversees or manage clinical documentation and reports.
  • Accurately updated and maintained clinical systems within project timelines.
  • Provided regular updates of study progression to CTM, Clinical Development Lead, Program Management, and other stakeholders.

Clinical Research Coordinator

MD Anderson
Houston, TX
01.2010 - 12.2011
  • Supported the clinical project team in the management of clinical trials.
  • Accurately updated and maintained clinical systems within project timelines.
  • Prepared, handled, distributed, filed, and archived clinical documentation and reports.
  • Reviewed study files periodically for accuracy and completeness.
  • Prepared, handled and distributed Clinical Trial Supplies and maintenance of tracking information
  • Tracked and managed 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.
  • Performed administrative tasks to support team members with clinical trial execution as needed.

Education

Bachelor of Science - Biology

Texas Southern University
Houston, TX

Skills

  • Leadership and Team Management
  • Project Management
  • Financial Management
  • Vendor Management
  • Data Management and Analysis
  • Clinical Monitoring
  • Clinical Operations
  • ICH GCP Guidelines
  • Regulatory Knowlegde
  • IRB Regulations
  • Ethical and Patient- Focused Approach
  • Inspection Readiness
  • Problem Solving and Decision-Making
  • Strong planning and organizational skills
  • Communication Skills
  • Clinical Trial Oversight

Therapeutic Areas

  • CNS: ADHD
  • PSYCHIATRY: Schizophrenia
  • ONCOLOGY: Lung Cancer (NSCLC), Breast Cancer, Solid Tumor, Leukemia, Glioblastoma Multiforme (GBM), Ovarian Cancer, Lymphoma.
  • INFECTIOUS DISEASES: Influenza, HIV, COVID-19
  • PULMONARY DISEASE: COPD
  • RARE DISEASES: CIDP
  • OPTHAMOLOGY: Achromatopsia
  • MEDICAL DEVICE: Heart Failure, Cardiac Rhythm Management,Structural Heart, Peripheral Intervention.

Certification

  • Project Management Professional (PMP)
  • ICH GCP

Vendor System

  • EDC: Medidata Rave, Inform, Trialmaster and Medrio ·
  • CTMS: VeevaVault and Icotrial ·
  • ETMF: VeevaVault and Wingspan ·
  • IWRS: Suvoda and Endpoint

Timeline

Clinical Trial Manager

AbbVie
02.2018 - Current

Senior Clinical Research Associate

Syneos
05.2014 - 01.2018

Clinical Research Associate I & II

PRA Health Sciences
01.2012 - 05.2014

Clinical Research Coordinator

MD Anderson
01.2010 - 12.2011

Bachelor of Science - Biology

Texas Southern University

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Oluwatomi Ojo