Bausch Health - Des Moines, IA
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 also assist in the evaluation and analysis of clinical trial data, contributing to the completion of reporting requirements and submissions to regulatory bodies. The role requires collaboration with various internal teams, including Clinical Operations, Research and Development, and Regulatory Affairs, to ensure that all aspects of the clinical trials are executed efficiently. The Manager will also be involved in technical writing projects, such as white papers and manuscripts, and will serve as a liaison between internal and external stakeholders. This position requires strong analytical skills, the ability to interpret medical literature, and excellent communication skills to present clinical information effectively.