Our LATAM clinical trial activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Study Start Up team in Buenos Aires This position plays a key role in the study start up 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 integral 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.

Qualifications

*We kindly ask that you submit your CV in English*
At least 4 years of regulatory submissions/start-up management experience (leading regulatory/start-up project teams);
Knowledge and experience of Clinical Trial Applications within Latam;




Strong oral and written communication skills;
Team oriented approach and strong leadership skills;
Willing to work in an office-based model; and
Fluency in English & local language

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edg

📌 Study Start Up Manager (Buenos Aires)
🏢 Medpace
📍 Buenos Aires