Kenneth Sezobo
Senior Clinical Trial Manager
- Role
- Senior Clinical Trial Manager at Endo-Therapeutics, Inc
- Location
- West Orange, NJ, US
- LinkedIn followers
- 500 followers
Experience
Senior Clinical Trial Manager
Jan 2024 — Present
Oversaw the execution of clinical monitoring and site management activities, including site selection, initiation visits, routine monitoring, and close-out visits, ensuring adherence to protocols and regulations.• Conducted regular sign-off visits and performance assessment visits for CRAs, evaluating their competencies and providing feedback to improve performance.• 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.• Oversee the quality and scientific integrity of global clinical studies.• Line management of Local Trial Managers.• Collaborate with cross-functional stakeholders to ensure timely and on-budget execution of clinical trial deliverables.• Lead the Clinical Study Team to drive effective decision-making.• Plan and manage the reporting of clinical studies through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables.• Ensure implementation and conduct of studies in accordance with SOPs and ICH-GCP guidelines.• Manage study budgets and timelines.• Manage vendors to the required standards.
Education
Olabisi Onabanjo University(O.O.U)
Bachelor's degree, Microbiology, General
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