Teni O
Clinical Trial Manager @Amgen
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WORK HISTORY
Clinical Trial Manager @Amgen
Actively collaborate with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial deliverables.• Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out in accordance with ICH-GCP and other applicable local regulations.• Accountable for site-level goal setting and study-specific deliverables for clinical sites.• Contribute and develop program, study-specific materials- e.g, monitoring plan, study specific training documents.• Contribute to deliver and / or lead CRA, Investigator and Study Coordinator training.
EDUCATION
University of Wales
MSc
University of Portsmouth
Bachelor of Arts - BA, International relations and Politics
ABOUT TENI O
Clinical Trial Manager with nine (9) years of experience in the conduct and management of all phases (I – IV) of clinical research trials. Strong skills and knowledge of clinical trial operations. Versed in managing operational aspects of clinical trials from start-up to close-out in adherence to regulatory requirements, timelines and budgets. Eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Extensive experience in the performance of all visit types (Pre-Site Selection visit, Site Initiation visit, Interim Monitoring Visits and Site Closeout Visit) in accordance with protocols, SOPs, ICH GCP guidelines and all FDA/ regulatory requirements. Excellent communication abilities and a stellar reputation for problem solving and improving site relationship.
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