.Job Summary:Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Study Start-Up Manager (Regulatory Submissions Manager) to support our growing Study Start-Up/Regulatory Submissions team at Medpace! This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.Responsibilities:- Efficiently manage and successfully execute all aspects of global start-up; - Perform quality checkson submission documents and site essential documents; - Prepare and approve informed consent forms; - Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and- Present during biddefenses, general capabilities meetings, and audits.Qualifications:- At least 4 years of experience in clincial research, preferably with a CRO, including at least 2 years of experience leading regulatory/start-up project teams; - Knowledge and experience of Clinical Trial Applications within Latam; - Strong oral and written communication skills; - Team oriented approachand strong leadership skills; and- Fluency in English.Medpace Overview:Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. 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. Headquartered in Cincinnati, Ohio, employing more than 4,000 people across almost 40 countries.Why Medpace?:When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.**Organic Growth**:***Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO