Bausch Health - Augusta, ME
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, data management, and ensuring that all necessary documentation is completed accurately. The role requires collaboration with various departments, including Clinical Operations, Research and Development, and Regulatory Affairs, to facilitate the smooth execution of clinical trials. The Manager will also be involved in the evaluation and analysis of clinical trial data, assisting in report writing and submissions to regulatory bodies. They will track study-specific payments and provide operational support to ensure that departmental procedures are efficiently completed. The position requires strong communication skills, as the Manager will liaise between internal and external stakeholders and present clinical information related to specific projects. This role is suited for an individual with a strong background in clinical trials, particularly in the pharmaceutical or medical device industry, and who possesses excellent analytical and problem-solving skills. The Manager will work on projects of moderate to high complexity, requiring a thorough understanding of clinical factors and scientific perspectives.