Clinical Trials Manager Jobs

Based in Oakland, NJ, Topcon is a comprehensive diagnostic device manufacturer within the worldwide eye care community. It introduced the world’s first commercial back-of-the-eye Spectral Domain (SD) and Swept Source (SS) optical coherence tomography (OCT) systems, which have driven innovation in eye care.
More recently, to develop the most efficient, pragmatic and state-of-the-art solutions, Topcon formed a new strategic division, Topcon Healthcare Solutions, whose primary objective is to create world-class software solutions for the eye care industry and beyond. The company's products enable the collection and visualization of a wide range of imaging and clinical data while providing quantitative and clinical analysis capabilities.
Topcon’s software gives clinicians access to patient exam data captured from OCTs, Visual Fields, Fundus Cameras, and other Topcon and third-party devices. Topcon leverages its new data management system called Topcon Harmony, where practitioners gain access to both DICOM and non-DICOM information stored in a central, cloud-based environment. Additionally, Topcon now provides an integrated service that connects practitioners to an extensive network of reading services to assist in the management of sight-threatening eye diseases.
At the Topcon Healthcare Innovation Center (THINC), we aspire to transform Topcon and patients’ lives by making personalized & digital medicine in eye care a reality. Powered by data-science and digital technologies, we drive solutions to advance research, clinical care, and patient empowerment. Our team strives for real impact through excellence, innovation, and collaboration.
Demands for medical device evidence development addressing patient safety, therapeutic efficacy, quality design and performance, risk management, and benefit-cost determinations are increasing. In accordance with the THINC mission to advance healthcare solutions, we are seeking a Clinical Trials Manager to support THINC’s initiatives to bring medical solutions to the market quickly and cost-effectively. This candidate will be responsible for ensuring that all clinical trials required for regulatory approval of our innovative hardware and software solutions are conducted in compliance with regulatory requirements and company policies. This is a full-time position located in our San Diego THINC headquarters.
Core Responsibilities

• Adverse Event Management: Assist in the identification and reporting of adverse events and ensure that they are handled appropriately
• Initiatives: Support in the development and execution of clinical trial operational improvement initiatives to enhance productivity, effectiveness, and/or cost savings (e.g., SOP development, WI’s, tools, etc.) from job summary
• Coordination of Clinical Trials: Assist in coordinating all aspects of clinical trials, including the preparation of clinical trial documents and materials, site initiation, participant recruitment and enrollment, monitoring, and close-out activities
• Site Management: Ensure that clinical trial sites are properly trained and prepared to conduct the study, maintain productive communication with site staff and investigators, and troubleshoot any issues that arise during the study
• Regulatory Compliance: Ensure that the clinical trial is conducted in compliance with GCP, applicable regulations, guidelines, protocols, and SOPs which includes obtaining regulatory approvals, proper and timely reporting, and maintaining all required study documentation
• Communication and Collaboration: Work closely with study coordinators, investigators, sponsors, and other team members to ensure that the clinical trial is conducted smoothly and efficiently, to establish study timelines and milestones, to track study metrics and provide periodic updates, and provide general administrative support
• Monitoring: Conduct monitoring visits at clinical sites, collect and review data and documents for accuracy and completeness, and ensure regulatory compliance
• Data Collection and Management: Perform and manage data review process on an ongoing basis to verify accuracy and completeness of study data, perform data entry into applicable databases, and assist with data analysis and study reports

Education & Experience

• Bachelor’s degree in a relevant scientific discipline
• Experience with managing study budgets and timelines
• Ability to travel up to 30% domestically
• 5+ years of experience managing clinical trials in a medical device or pharmaceutical company
• Ability to manage multiple priorities and work effectively in a fast-paced environment
• Excellent communication and interpersonal skills
• Strong knowledge of FDA regulations and GCP guidelines