Bausch Health - Annapolis, MD
posted 2 months ago
Bausch + Lomb is seeking a Manager for Clinical Trials in Ophthalmology to lead and collaborate on various tasks essential for the successful commencement and execution of clinical trials. This role involves significant responsibilities including clinical planning, protocol development, and communication with clinical trial sites. The Manager will oversee compliance with FDA regulations and company standard operating procedures during all clinical investigations and post-market studies. This position requires effective communication with vendors and clinical trial sites to ensure adherence to protocols and Good Clinical Practice (GCP) requirements. The Manager will also be responsible for the verification and tracking of case report forms (CRFs), generating Data Clarification Forms (DCFs) for any missing or inaccurate data, and ensuring that all data changes are accurately captured in the database. Additionally, the role includes assisting in the evaluation and analysis of clinical trial data, which is crucial for meeting reporting requirements, including report writing and submissions to the FDA and scientific journals. Collaboration is key in this position, as the Manager will work closely with various teams including Clinical Operations, Research and Development, Safety, and Marketing. The role also involves leading technical writing projects such as white papers and manuscripts, and presenting clinical information to stakeholders. The ideal candidate will have a strong background in clinical trials, excellent communication skills, and the ability to work independently while managing multiple projects of moderate to high complexity.