Irving (Dallas), Texas28 days ago
Responsibilities : Efficiently manage successful execution of global start-up, maintenance, and close-out studies; Effectively lead others in a matrix environment; Perform quality checks on submission documents and site essential documents; Prepare and approve informed consent forms; Serve as a Sponsor point of contact for start-up and regulatory submissions items; Review pertinent regulations to develop proactive solutions to start-up challenges; Prepare new business proposals and present during bid defenses, general capabilities meetings, and audits; Contribute to the growth and development of departmental staff, processes and systems. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.