Tunde Ogunyemi
Senior Associate Clinical Project Manager- (Neuromodulation- Obstructive Sleep Apnea) @LivaNova
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WORK HISTORY
Senior Associate Clinical Project Manager- (Neuromodulation- Obstructive Sleep Apnea) @LivaNova
Houston, TX, US
Develops Clinical Investigational Plan (study Protocol), other study required documents for study initiation and facilitate regulatory submissions. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws & regulations, protocol, site monitoring plan and associated documents. Participates & provides inputs on site selection and qualification activities for new studies. Responsible for the planning and execution of remote and on-site monitoring activities to ensure the accuracy and completeness of data and that study participant’s rights, safety, and wellbeing are protected. Conducts & oversees site visits i.e, Site qualification visits, initiation visits, monitoring visits, and close-out visits. Records clear, comprehensive, and accurate visit reports appropriately in a timely manner. Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, adverse events, regulatory documentation, site audits/inspections, and overall site performance. Identifies, assesses, and resolves site performance, quality, or compliance problems and escalates any issues to the Clinical Program Manager. Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Trains investigational site personnel on study protocol, study-specific Case Report Forms (CRFs), regulatory document maintenance, and EDC system use. Contributes strongly to team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. Oversees activities of CRAs/Clinical Monitors, including training, site issues resolution and providing support. Reviews and approves reports completed by CRAs/Clinical Monitors
EDUCATION
Nottingham Trent University
Master of Science - MS, Biotechnology
Obafemi Awolowo University
Bachelor of Science - BS, Microbiology
University of Ilorin, Nigeria
Medicine and Surgery
SKILLS
ABOUT TUNDE OGUNYEMI
Tunde is a certified, high skilled Clinical research professional with more than 10 years diverse research experience ranging from site coordination, in-house/remote project monitoring to on-site monitoring of drugs and device clinical trials. His exceptional expertise and versatility has made clinical study monitoring, not just a job he loves but a clarion call to be part of what makes the world a better place. He currently manages a multicenter clinical study for an active Implantable Medical Device (AIMD), with study sites in the United States, Europe and Israel. Therapeutic experience: Neurology( neuromodulation), Cardiovascular, Respiratory care, Sleep Medicine, Infectious Diseases, Oncology, Endocrinology, Osteology, Internal medicine. Highly proficient in the use of electronic clinical trial management system such as:• Bioclinica IBM CTMS. Electronic Data Capture (IBM eClinical, Medidata Rave, Inform GTM, Medrio Proficient in Computer skills and emails, expert in Microsoft Office Suite (Word,Outlook, Excel and PowerPoint). Sound verbal communication and excellent reporting abilities. Excellent skills in time management and multitasking, ability to meet deadlines. Ability to work independently in a fast paced, result- oriented environment, consistently delivering high quality work with a remarkable track record of providing the best services. Exceptional mentor and trainer with skills to achieve peak individual performance from peers and team members.
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