Bausch Health - Lincoln, NE
posted 2 months ago
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. In this role, you will lead or collaborate on required tasks prior to the commencement of clinical trials, which include clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection, and communication with clinical trial sites regarding all logistics including contract agreements, support materials, and training. You will provide clinical oversight and management for clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all company clinical investigations and post-market studies. You will communicate with vendors and clinical trial sites regarding study conduct, data monitoring, and logistical management of follow-up and close-out study visits to ensure compliance with protocols and GCP requirements. Collaborating on clinical data processing in accordance with departmental SOPs and guidelines will also be part of your responsibilities. You will verify, review, and track CRFs and generate Data Clarification Forms (DCFs) for all missing or inaccurate data, ensuring that data changes are properly implemented and captured in the database or data system. Additionally, you will assist in the evaluation and analysis of clinical trial data to facilitate completion of clinical trial reporting requirements, including report writing, clinical photo-documentation, FDA, and manuscript submissions. Your role will also involve tracking study-specific payments and providing operational or workflow support to assure that departmental and cross-functional systems and procedures are efficiently and correctly completed. You will collaborate on project teams, primarily with Clinical Operations, Research and Development, Safety, Clinical Trial Materials, Marketing, Regulatory, and Quality/Compliance. Leading or collaborating on technical writing projects, which include white papers, abstracts, manuscripts, and literature reviews, will be expected. You will act as a liaison between internal and external stakeholders to facilitate cooperation and conduct presentations of clinical information concerning specific projects. You will work on projects of moderate-to-high degree of difficulty, where analysis of situations or data requires review of identifiable clinical factors and incorporation of scientific and clinical perspectives.