Bausch Health - Columbus, OH
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 and ensure adherence to protocols and Good Clinical Practice (GCP) requirements. The Manager will provide clinical oversight throughout the trials, ensuring compliance with regulatory requirements and company SOPs. This includes managing data monitoring, follow-up, and closeout study visits. The role also involves collaborating on clinical data processing and assisting in the evaluation and analysis of clinical trial data, which is essential for meeting reporting requirements. The Manager will track study-specific payments and provide operational support to ensure efficient completion of departmental and cross-functional systems and procedures. In addition to these responsibilities, the Manager will lead or collaborate on technical writing projects, including white papers and manuscripts, and serve as a liaison between internal and external stakeholders. The position requires conducting presentations on clinical information and working on projects that require a high degree of analytical skills and scientific perspective. This role is critical in advancing Bausch + Lomb's mission to enhance eye health and improve patient outcomes.