Ola Gbenro Email & Phone Number

Georgia, United States

United States

Leads internal and external cross-functional Project Teams, overseeing day-to-day operations, to achieve project objectives in alignment with corporate targets, i.e. enrollment, site activation, and financial performance goals.• Manages assigned clinical trials, Phases I-IV, for investigational devices in accordance with the Clinical Investigational Plan (CIP), applicable Standard Operating Procedures (SOPs), federal and local regulations, ISO standards, and ICH-GCP guidelines. Manages CROs/vendors, when services are outsourced, providing oversight of contracted deliverables and parameters; may serve as key member of governance or oversight committees• Accountable for project financial planning, management, and change control, including vendor contracts and budgets, change orders and amendments, invoice review, budget reconciliations and forecasting• Leads the selection and contracting of vendors, including reviewing Scope of Work (SOW) in collaboration with clinical procurement• Provides oversight of and drives project communications across functional areas, including regular status updates, project tracking, and project reporting2• Supports in the development and evaluation of Key Performance Indicators (KPIs) throughout the trial• Develops and manages the project timeline, forecasting and tracking milestones• Develops or oversees the development and implementation of cross-functional clinical trial documents, including but not limited to: Protocols, ICF Templates, CRFs, study plans, manuals, site-facing materials, and Clinical Study Reports (CSRs)• Oversees the development, maintenance, and final transfer of the electronic Trial Master File (eTMF); oversees routine TMF review• Oversees and/or assists with IRB/IEC and regulatory submissions and meetings as required; liaises with global team to ensure alignment with study objectives and milestones• Oversees internal Project Team training and tracking of training documentation• Performs risk management

•Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders.•Assists with plans and management of day-to-day operational aspects of one or more assigned programs/projects or tasks, including the following, as required: planning/timelines, budgeting/resourcing, and vendor management/interfacing. •Responsible for planning, scheduling, and implementing 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.•Interfaces with client and program/project staff; ensures provision of meeting agendas and summary documentation and detailed information as required for internal and client meetings.•Lead and actively participate in the conduct of clinical team meetings. Prepare sections for monthly, quarterly, and annual reports; and, present at internal and/or scientific meetings.•Oversight of visit report review and approval, including site issue escalation and resolution. This may involve direct review/approval of site visit reports, and interacting with other Managers. •Responsible for the development and maintenance of operational plans for clinical deliverables e.g., eCRF completion guideline, Clinical Monitoring Plan (CMP), Recruitment Plan, and Training Plans•Ensure the core clinical portions of the Trial Master File are up-to-date and maintained in accordance with SOPs.•Ensures project quality and compliance with FDA regulations and ICH (R2) guideline, and with NIH policies or other sponsors-specific requirements.•Provided oversight and mentorship to staff in the delivery of quality work and performance, as per task order and project deliverables, may include line management responsibility and staff hiring. Implement QC activities, ensure compliance with quality measures and monitor required quality metrics.

• Provides direction and leadership to multiple clinical operations project teams.• Coordinates & manages clinical deliverables from site start up activities to database lock.• Reviews clinical monitoring report• Provides day to day operational management of CRAs and CTAs (in-house and remote) to ensure delivery against contracted scope of work.• Ensures implementation of ICON’s SOPs and study specific processes.• Assists in identifying training and development needs and opportunities CRAs and CTAs.• Assigns appropriate project specific training for CTAs and CRAs.• Supports and interfaces with external vendors and clinical site personnel, as needed.• Provides input in the development of clinical trial related documents including but not limited to protocols, case report forms, informed consents, conventions/timelines, monitoring plans, site reference manuals, pharmacy manuals, laboratory manuals, training materials, and site initiation visit slide presentation.• Collaborates with applicable team members and client for feasibility assessment.• Assists in identifying suitable, qualified trial sites within a specified geographical area.• Initiates contact conducted evaluation visited and subsequently established relationships with selected trial sites to ensure study targets for recruitment, quality and costs are met.• Assists in supporting regulatory submissions.• Supervises shipment of study drugs and materials to the site as required.• Co-monitors study sites with assigned CRAs for assessment purposes.• Assists in ensuring audit readiness, by ensuring the eTMF/TMF is always up to date• Maintains study specific tracking tools (via Clinical Trial Management system).• Liaises with the Safety group in the management of serious adverse events (SAEs) and SAE reports, and ensure appropriate action is taken at the trial site .

• Worked independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation.• Visited sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure data collected from start up to termination of studies.• Data collection and overview of all aspects of the trial.• On-site monitoring for all visits from initiation to close-out.• Performed clinical data listings reviews as needed.• Completed and submits visit trip reports according to SOP requirements.• Assisted in development and implementation of clinical trials, coordinate assigned clinical trials and ensured compliance with GCP/ICH guidelines. • Performed investigative site file reconciliation, requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs and sponsor requirements.• Performed source document verification, retrieves case report forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites• Ensured Serious Adverse Event (SAE) reporting according to project specifications, reviews SAE information, resolves queries and assists sites in completion of SAE reports.• Generated reports for site and project management using CTMS.

• Performed initiation, study staff training, interim monitoring and close-out visits for multiple sites in accordance with SOPs and the CMP.• Traveled 70% - 80% to sites for on-site visits.• Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested• Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required.• Managing sponsor generated queries efficiently and responsible for study cost effectiveness• Reviewed monitoring reports and implemented follow-up or corrective action as needed• Ensured study documentation is completely and properly maintained in accordance with the sponsor protocol, SOPs, GCPs, ICH Guidelines and FDA regulations• Prepared and submitted of timely appropriate monitoring forms and site visit reports in accordance with the Project Operations Manual and SOPs• Monitored Investigator compliance for the reporting of Adverse Events and Serious Adverse Events.• Created and developed FDA compliant data management modules using Axis Clinical software products.• Monitored 6-8 protocols with varying indications at multiple sites across the country to ensure adherence to the protocol and compliance with ICH guidelines, GCPs and FDA regulations.• Thoroughly communicated with principal investigators and their staff members to resolve data.• Functioned as the primary point of contact between sponsor.