Topcon Healthcare sees eye health differently. Our vision is to empower providers with smart and efficient technologies for enhanced patient care. Keeping pace with the ever-changing landscape of the healthcare industry, we offer the latest integrated solutions including advanced multimodal imaging, vendor-neutral data management and groundbreaking remote diagnostic technology. A globally-oriented business, Topcon is focused on developing solutions towards solving societal challenges in the mega-domains of healthcare, agriculture, and infrastructure. In healthcare, these challenges include increasing eye disease, rising medical costs, access to healthcare and physician shortages. By investing in value-driven innovations, Topcon works to enable people to enjoy good health and a high quality of life.

Learn more about working with us at topconcareers.com

Summary:

The Clinical Trials Manager is responsible for leading Topcon Healthcare's clinical trials in preparation for regulatory submission. In this role the Clinical Trials Manager will implement and oversee projects providing regional and global insight. This individual will work as part of a cross-functional team including; Clinical & Medical Affairs, Product Management, Research & Development, Operations, Regulatory, Legal and other internal and external stakeholders to harmonize clinical operations and clinical trial activities.

Responsibilities:

• Clinical trial(s) management
• Oversight of the CRO, other study service providers, and consultants involved in a clinical trial
• Establish study milestones and accurately track and report study metrics and timelines
• Ensure clinical trials are managed and executed in accordance with GCP, regulations, the protocol, and company-specific SOPs
• Assist in preparation and review of clinical trial documentation including; protocol, informed consent, project plan, case report forms, clinical study reports, and other study level documents
• Proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required
• Assesses operational feasibility, recommending study execution plan and site selection
• Perform and manage data review process on an ongoing basis
• Perform site visits including site qualification, initiation, and close-out visits and monitoring as needed
• Review monitoring reports to ensure quality and resolution of site-related issues
• Ensures tracking and review of protocol deviations and assesses impact on study data

Qualifications

• Bachelor's Degree
• 5+ years of clinical research experience within the eye care industry, medical device experience preferred
• Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
• Knowledge of GCP and regulatory requirements for clinical trial management
• Experience with regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners
• Excellent communication, organizational, conflict resolution, prioritization and negotiation skills
• Proven ability in creative problem-solving and exercising sound judgment
• Ability to handle a high volume of highly complex tasks within a given timeline

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Topcon is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.