Olutoyin Adedayo
Sr. Trial/Project Manager
Morris Plains,NJ
Summary
Dynamic clinical research professional with extensive hands-on experience in Trial Management and a talent for navigating challenges. Brings strong problem-solving skills and proactive approach to new tasks. Known for adaptability, creativity, and results-oriented mindset. Committed to making meaningful contributions and advancing organizational goals.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Sr. Project (Trial) Manager
Cancer Trials Centre, University College London
11.2022 - Current
- Manage multiple trials, overseeing daily operations to ensure timely completion of projects while adhering to ICH/GCP guidelines and relevant regulations.
- Support cross-functional teams, providing expertise on project related issues.
- Manage vendors and third-party organizations - prepare requirements for vendor identification, vendor selection, project scope, monitoring, and issue resolution.
- Responsible for global study start-up – document review, study plan and systems development
- Achieved a 20% reduction in site activation time, by identifying complexities and implementing strategies that were more site and patient-focused.
- Lead the development of essential trial documents, trial plans, manuals, reports, collaborating with relevant key opinion leaders (KOLs).
- Work together with trial functional teams in building relevant systems (EDC, clinical trial management systems), writing standard procedures and highlighting training requirements.
- Manage the writing of country and global specific documents towards initial submissions and subsequent amendments.
- Manage the site selection process (feasibility, registration, activation), maintenance, and overseeing the trial processes.
- Facilitate site engagement and communications with investigators and research staff to resolve issues and to support trial milestones and deliverables.
- Oversee budget management - allocation and expenditures, to maximize resources and maintain financial stability to meet project goals and timelines, including oversight of tracking systems.
- Manage contracts – negotiations and ensuring all relevant agreements are in place.
- Guiding team members in their career growth, training and mentoring.
- Lead trial teams, ensuring accurate and up-to-date trial information is available within relevant tracking systems.
- Provide regular trial updates to internal Leads, and other stakeholders on project deliverables and milestones.
- Proactively identify and address issues that arise during trial execution and handle the escalation of trial-related challenges.
- Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team.
- Work closely with the data management team to ensure timely data cleaning, data analysis, quality results and final report, in alignment with project goals.
- Participate in and facilitate training for trial teams, investigators, and site trial teams.
- Provide oversight and direction to trial team members for trial deliverables.
- Oversee the set-up of the TMF, ensuring quality and completeness, and facilitating training as required.
Clinical Trial Coordinator (Trial Manager)
Cancer Trials Centre, University College London
11.2008 - 10.2022
- Managed multiple projects concurrently without compromising quality or attention to detail.
- Conducted centralized monitoring, address any issues, and maintain open lines of communication with investigators.
- Developed strong relationships with key stakeholders, fostering a collaborative environment for successful clinical trials.
- Maintained comprehensive knowledge of regulations, staying current on updates or changes that could impact the clinical trial process.
- Participated in cross-functional team meetings to provide updates on trial progress and discuss potential areas for improvement or optimization.
- Conducted thorough feasibility assessments for potential trial sites, ensuring appropriate resources were available for successful study execution.
- Carried out site initiation visits and site activation.
- Conducted site visits to monitor progress, address any issues, and maintain open lines of communication with investigators.
- Prepared regulatory submissions, ensuring completeness and accuracy of all required documentation.
- Maintained Clinical Trial Management Systems (CTMS), Trial Master Files (eTMF and paper), and document control of all trial specific documents.
Education
Master of Science - Medical Statistics
London School of Hygiene & Tropical Medicine
London, United Kingdom 05.2001 -
Skills
Team Leadership
Certification
Association of Clinical Research Professionals - Certified Professional (ACRP-CP)
Timeline
Association of Clinical Research Professionals - Certified Professional (ACRP-CP)
07-2024
Sr. Project (Trial) Manager
Cancer Trials Centre, University College London
11.2022 - Current
Clinical Trial Coordinator (Trial Manager)
Cancer Trials Centre, University College London
11.2008 - 10.2022
Master of Science - Medical Statistics
London School of Hygiene & Tropical Medicine
05.2001 -
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