Manager - Regulatory Submissions (Study Start-up)

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. This position plays a key role inthe clinical trial managementprocess 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.

• 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; and
• Present during bid defenses, general capabilities meetings, and audits.

• At least 4 years of experience in clinical research, preferably with a CRO, including at least 2 years of experience in a regional/global start up management;
• Advanced level of English (strong written & verbal communication skills);
• Excellent interpersonal and organizational skills; and
• Team oriented approach and strong leadership skills.