Manager - Regulatory Submissions (Study Start-up)

Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Clinical Operations team in Leuven, Belgium. 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 checks on 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;
• Present during bid defenses, general capabilities meetings, and audits.

Qualifications

• At least 4 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience
• Knowledge and experience of Clinical Trial Applications within Europe
• Strong oral and written communication skills
• Team oriented approach and strong leadership skills
• 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.