Bausch Health - Bismarck, ND
posted 2 months ago
Bausch + Lomb is seeking a Manager for Clinical Trials in Ophthalmology to join our team in Bismarck, North Dakota. This role is pivotal in leading and managing clinical trials that are essential for the development and approval of our ophthalmic products. The successful candidate will be responsible for overseeing all aspects of clinical trial management, ensuring compliance with FDA regulations and company standard operating procedures (SOPs). This includes the planning and execution of clinical trials, from protocol development to site selection and communication with clinical trial sites. The Manager will also provide clinical oversight during the trials, ensuring that all activities are conducted in accordance with Good Clinical Practices (GCP) and regulatory requirements. In this role, you will collaborate with various departments including Clinical Operations, Research and Development, and Regulatory Affairs to ensure the successful execution of clinical studies. You will be responsible for managing the logistics of clinical trials, including vendor communication, data monitoring, and the management of follow-up and close-out study visits. Additionally, you will assist in the evaluation and analysis of clinical trial data, contributing to the completion of clinical trial reports and submissions to regulatory bodies. The Manager will also play a key role in technical writing projects, including the preparation of white papers, abstracts, and manuscripts. You will serve as a liaison between internal and external stakeholders, facilitating cooperation and communication throughout the clinical trial process. This position requires a strong analytical mindset, excellent communication skills, and the ability to work independently while managing multiple projects of varying complexity.