Jeremy O.
Senior Clinical Trial Manager | Expert in Neurology, Oncology & Rare Diseases | Driving Results through Effective Leadership & Risk Management
- Role
- Senior Clinical Trial Manager at Hanmi Pharmaceuticals
- Location
- Houston, TX, US
- LinkedIn followers
- 500 followers
About Jeremy O.
As a seasoned Clinical Trial Manager with over a decade of experience, I excel in…
Experience
Senior Clinical Trial Manager
Jun 2022 — Present · US
Lead operational management of complex clinical trials across multiple therapeutic areas, ensuring the successful execution of all trial phases in compliance with ICH-GCP guidelines, regulatory requirements, and company SOPs- Collaborate with cross-functional teams to develop clinical study deliverables, including protocols, informed consent forms, and case report forms (CRFs), driving high-quality trial initiation and execution- Oversee vendor and CRO relationships, negotiating contracts, managing scopes of work (SOWs), and ensuring adherence to project timelines, budgets, and quality standards- Manage study site performance, including patient recruitment, enrollment metrics, and compliance with regulatory requirements, achieving high site activation success rates- Implement risk-based monitoring strategies to proactively identify and address potential issues, reducing protocol deviations and ensuring data integrity- Direct clinical trial budgets, overseeing financial planning, accruals, and invoicing, while optimizing resources within a $10M+ budget framework- Provide strategic oversight for data management activities, working closely with cross-functional teams to perform data cleaning, resolve queries, and lock databases with high accuracy- Mentor junior staff, fostering professional development and enhancing team proficiency in clinical trial operations and compliance- Chair key internal and external meetings, including investigator meetings and project progress reviews, ensuring seamless communication across stakeholders- Contribute to process improvement initiatives, optimizing workflows and enhancing the efficiency of trial management activities- Ensure audit readiness, maintaining comprehensive documentation within the electronic Trial Master File (eTMF) and conducting sponsor quality monitoring visits to verify adherence to protocols and GCP.
Education
University of Port Harcourt
Bachelor of Science - BS
University of Port Harcourt
Master of Science - MS
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