Study Start Up Manager

Medpace; Buenos Aires; On-site; BRL 312,000 - 520,000; Full time

Benefits offered by this job

Flexible work environment

Competitive compensation and benefits package

Structured career paths

Company-sponsored employee appreciation events

Health and wellness initiatives

Employee wellness initiatives

Job summary

A global clinical research organization is seeking a full-time Regulatory Submissions Manager in Buenos Aires. This role requires at least 4 years of regulatory submissions experience, particularly with Clinical Trial Applications in LATAM. The manager will oversee all aspects of global start-up processes, perform quality checks, and prepare essential documents. Strong communication skills in English and a team-oriented approach are mandatory. The organization offers flexible work, competitive compensation, and opportunities for professional growth.

Qualifications

• At least 4 years of regulatory submissions/start‑up management experience.
• Knowledge of Clinical Trial Applications within LATAM.
• Willingness to work in an office‑based model.
• Strong oral and written communication skills.
• Team-oriented approach with strong leadership skills.
• Willing to work in an office-based model.

Responsibilities

• Efficiently manage and execute all aspects of global start‑up.
• Perform quality checks on submission documents.
• Prepare and approve informed consent forms.
• Review regulations to develop proactive solutions.
• Present during bid defenses and audits.

Skills

Regulatory submissions management

Strong oral communication

Strong written communication

Team-oriented approach

Fluency in English

Team collaboration

Office-based

Job description

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.

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

• 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.
• Fluency in English and the local language.

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, we employ more than 5,000 people across almost 40 countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

• Flexible work environment.
• Competitive compensation and benefits package.
• Competitive PTO packages.
• Structured career paths with opportunities for professional growth.
• Company‑sponsored employee appreciation events.
• Employee health and wellness initiatives.

Awards

• Recognized by Forbes as one of America’s Most Successful Midsize Companies in 2021, 2022, 2023, and 2024.
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.

What To Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Seniority level

Not Applicable

Employment type

Full‑time

Job function

Research, Analyst, and Information Technology

Industries

Pharmaceutical Manufacturing