Bausch Health - Helena, MT
posted 2 months ago
Bausch + Lomb is seeking a Manager for Clinical Trials in Ophthalmology to lead and oversee clinical trial activities. This role is pivotal in ensuring that clinical trials are conducted in compliance with FDA regulations and company standard operating procedures. The Manager will be responsible for a variety of tasks prior to the commencement of clinical trials, including clinical planning, protocol development, and site selection. This position requires effective communication with clinical trial sites and vendors to manage logistics, contract agreements, and training materials. The Manager will also provide clinical oversight during trials, ensuring adherence to Good Clinical Practices (GCP) and regulatory requirements. In addition to overseeing trial conduct, the Manager will collaborate on clinical data processing and assist in the evaluation and analysis of clinical trial data. This includes generating Data Clarification Forms (DCFs) for any missing or inaccurate data and ensuring that all changes are accurately captured in the database. The role also involves writing clinical reports, assisting with FDA submissions, and tracking study-specific payments. The Manager will work closely with various departments, including Clinical Operations, Research and Development, and Regulatory Affairs, to ensure that all systems and procedures are efficiently completed. The position requires strong analytical skills, the ability to interpret medical literature, and excellent verbal and written communication skills. The Manager will also be involved in technical writing projects, presentations, and liaising with internal and external stakeholders to facilitate cooperation. This role is essential for the successful execution of clinical trials and the advancement of eye health initiatives.