Adeniyi Kelani
Houston,TX
Summary
Experienced Senior Clinical Trial Manager with years of expertise managing Phase III clinical trials in the US, including hands-on start-up experience in the biotech sector. Skilled in coordinating cross-functional teams, overseeing vendor and CRO relationships, and ensuring compliance with FDA/EMA regulations and ICH/GCP guidelines. Proficient in IND submissions, FDA communications, and managing trial budgets, proposals, and RFPs. Known for proactive issue resolution, maintaining inspection readiness, and delivering studies on time and within budget. Strong sponsor-side experience with a focus on oncology and radiopharmaceuticals. Stable work history with 2-3 years in previous roles, demonstrating long-term commitment and success in clinical trial management.
Overview
9
9
years of professional experience
Work History
Sr. Clinical Trial Manager
Legend Biotech
02.2023 - Current
- Developed timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures
- Developed clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
- Provided leadership and direction to clinical site management team members from study start through to closure
- Reviewed monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters
- Worked with head of Site Operations to ensure overall quality and project services, proactive issue resolution and development of systems to standardize and improve clinical trial management practices across all functional areas
- Monitored study progress through regular review of CTMS, CRF, drug management, safety data, and data visualization dashboards, proactively identifying and addressing potential issues
- Developed and implemented comprehensive clinical management plans and site management plans for numerous clinical studies, outlining clear roles and responsibilities, timelines, and quality standards
- Collaborated with the regulatory team to ensure timely submissions and approvals to competent authorities and IRB/Ethics committees
- Supported the legal department in site budget and contract negotiations, ensuring fair and favorable terms for the company
- Developed clinical monitoring strategies that optimized study timelines and ensured high-quality deliverables
- Generated and utilized metric reports to track study progress, identify trends, and communicate potential issues to the project manager and CRAs
Clinical Trial Manager
George Clinical
02.2021 - 05.2023
- Provided guidance and support to study sites to ensure adherence to protocols and Good Clinical Practice (GCP) guidelines
- Worked closely with vendors and contract research organizations (CROs) to ensure high-quality and timely execution of trials
- Trained and mentored junior team members on trial management processes and procedures
- Managed, coordinated, and oversaw the activities from third party service providers including timelines, contract deliverables, metrics, accruals, and implementation
- Tracked and maintained studies, including study status, enrollment, deviations, documents, and plans
- Supported oversight of clinical site performance, metrics, and monitoring visits
- Assisted and supported study data related activities including data review, query creation and resolution, study and protocol deviation reviews, and safety reviews
- Coordinated remote review of clinical data within EDC system
- Assisted Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization
- Effectively tracked and communicated program/study progress to Senior Management with ability to create and update detailed dashboards and trackers
- Acted as liaison with Regulatory Affairs to assure adherence to GCPs; maintenance of SOPs; and assure site and CRO/vendor audits are completed
- Collaborated with counsel to negotiate and draft research contracts and agreements with CROs/vendors and clinical study sites, as needed
- Created realistic plans that clearly define goals, milestones, responsibilities and results
- Maintained focus on strategic objectives while accomplishing operational goals
Senior Clinical Research Associate
George Clinical
12.2019 - 02.2021
- Performed site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
- Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas
- Administered protocol and related study training to assigned sites and established regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Escalated quality issues to clinical project manager, clinical research specialist and/or line manager
Clinical Research Associate I/ II
IQVIA
07.2016 - 12.2019
- Established and maintains regular contact with investigators, vendors and study sites to ensure ICH-GCP protocol compliance, and assessment of accrual rates
- Ensured site compliance with study protocols, ICH-GCP, applicable regulations prior, during and following visits
- Works with site personnel and study team to prevent, address and resolve issues
- Ensured the integrity of the data submitted on CRFs or other data collection tools by careful source document review
- Collaborated with Study Management Team to drive successful execution of global clinical studies in rare diseases
- Documented monitoring activities in monitoring reports and follow-up letters
- Assisted in protocol feasibility analysis, contract assessment, site identification, and patient recruitment and planning
- Assisted in the creation of study materials (CRFS, operation manuals, protocols, etc.)
- Assisted in the creation of departmental operating procedures and tracking systems
- Acted as a liaison between site personnel and the sponsor
- Performed monitoring visits
- Ensured compliance with protocols, regulatory requirements, and good clinical practices
Clinical Research Coordinator
MD Anderson Cancer Center
08.2015 - 04.2016
- Conducted comprehensive site visits (QV, SIV, MV, TV) for multiple trials, ensuring adherence to protocol, GCP standards, and regulatory requirements, meticulously safeguarding patient safety and data integrity
- Assisted trial Investigator in screening and review of potential study participants eligibility
- Maintained case report forms, charts and documentation
- Performed miscellaneous job-related duties as assigned
- Managed studies with the sponsor, Site Director, and Principal Investigator to ensure compliance with protocol requirements
Education
B.Sc. - Biology
University of Porthacourt
Skills
- Clinical Trial Manager
- RFP Review
- Vendor & CRO Management
- Study Timeline & Budget Management
- Recruitment and Retention
- Regulatory Compliance and Audit
- EDC
- ETMF
- CTMS
- Cross-functional team leadership & collaboration
- Strong Communication and Presentation Skills
Areasofexpertise
Clinical Trial Manager, RFP Review, Vendor & CRO Management, Study Timeline & Budget Management, Recruitment and Retention, Regulatory Compliance and Audit, EDC, ETMF, CTMS, Cross-functional team leadership & collaboration, Strong Communication and Presentation Skills, ONCOLOGY: Breast Cancer, Multiple Myeloma, Prostate Cancer, NSCLC, RARE DISEASES: Cystic Fibrosis, Fabry Disease, Hemophilia, AUTOIMMUNE: Multiple Sclerosis, Type 1 Diabetes, Rheumatoid Arthritis, MEDICAL DEVICES: Cardiac Pacemakers, Dialysis Machine, Stents, CARDIOVASCULAR: Diabetes, Ischemic syndromes, Valvular heart disease
Timeline
Sr. Clinical Trial Manager
Legend Biotech
02.2023 - Current
Clinical Trial Manager
George Clinical
02.2021 - 05.2023
Senior Clinical Research Associate
George Clinical
12.2019 - 02.2021
Clinical Research Associate I/ II
IQVIA
07.2016 - 12.2019
Clinical Research Coordinator
MD Anderson Cancer Center
08.2015 - 04.2016
B.Sc. - Biology
University of Porthacourt
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