Study Start-up Specialist

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 5,000 people across 40 countries. Job Summary Our clinical operations activities are growing rapidly, and we are currently seeking a full-time office-based Regulatory Submissions Coordinator/Study Start-up Specialist to join our Clinical Operations team in Munich . 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. Entry-level positions with permanent contract are available for recent graduates. Responsibilities Prepare, review, and file clinical trial applications for Germany, Austria and Switzerland (DACH); Communicate with research sites in Germany, Austria and Switzerland (hospitals, etc.) to collect all essential documents required before the site starts to enroll patients to participate in the clinical trial; Provide insightful input on regulatory submissions documents and maintain timelines for study start-up through both internal and external collaboration; Ensure submissions comply with applicable regulations and guidance documents; Advise on changing country regulations and compliance requirements; and Track submissions and ensure timely filing of documents. Qualifications Bachelor\’s degree (preferably in a Life Sciences field); Interest in drug development and clinical trials; Full professional proficiency in German and English in written and verbal communication; Knowledge of Microsoft® Office; and Excellent organization and communication skills, great attention to detail. Travel: None We kindly ask to submit applications in English. We would appreciate if you could indicate the status of your work permit if needed.