Study Start Up Manager

Medpace; Buenos Aires; Presencial; ARS 1.000.000 - 1.400.000; Jornada completa

Descripción de la vacante

Medpace LATAM is seeking a full-time Regulatory Submissions Manager to join our Study Start Up team in Buenos Aires. This office-based role plays a key part in the study start up process, leveraging your regulatory and project leadership experience to deliver timely submissions.

You will work with cross-functional teams, perform quality checks on documents, review regulations, and present at audits and bid defenses.

Formación

• Submit CV in English
• At least 4 years of regulatory submissions/start-up management experience
• 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 & local language

Responsabilidades

• 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

Conocimientos

Regulatory submissions

Start-up management

Clinical Trial Applications LATAM

Fluent English

Fluent in local language

Strong communication skills

Team leadership

Descripción del empleo

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 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.

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-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

• Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

• Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
• Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

• Office based environment with on-site mentors
• Defined career paths with clear advancement opportunities
• Industry renowned onboarding and training programs designed to accelerate professional development
• Ongoing training and continuous learning opportunities throughout your career
• An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

• Competitive compensation programs that recognize and reward performance
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH that provides flexibility for eligible positions after training
• Company-sponsored social events

Please note benefits may vary based on country.