Bausch Health - Denver, CO
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. They will also manage communication with clinical trial sites regarding logistics, contract agreements, and training materials. In addition to overseeing the clinical trials, the Manager will provide clinical oversight to ensure compliance with Good Clinical Practices (GCP) and other regulatory requirements. This includes monitoring study conduct, managing data collection, and ensuring that all clinical trial data is accurately captured and reported. The Manager will collaborate with various departments, including Clinical Operations, Research and Development, and Regulatory Affairs, to facilitate the smooth execution of clinical trials. The role also involves technical writing responsibilities, such as drafting white papers, abstracts, and manuscripts, as well as presenting clinical information to internal and external stakeholders. The Manager will work on projects that require a moderate to high degree of difficulty, necessitating a thorough analysis of clinical data and the ability to interpret scientific literature. This position is essential for advancing Bausch + Lomb's mission of enhancing eye health and ensuring the successful development of new ophthalmic products.