Study Start Up Manager

Medpace; São Paulo; Presencial; BRL 120.000 - 160.000; Tempo integral

Resumo da oferta

A global clinical research organization in São Paulo is seeking a full-time Regulatory Submissions Manager to efficiently manage global start-up processes. The ideal candidate should have at least 4 years of experience in regulatory submissions management, strong communication and leadership skills, and fluency in English and the local language. This position offers a flexible work environment, competitive compensation, and career growth opportunities.

Serviços

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

Qualificações

• At least 4 years of regulatory submissions/start-up management experience.
• Fluency in English and local language is required.
• Willing to work in an office-based model.

Responsabilidades

• Manage and execute all aspects of global start-up.
• Perform quality checks on submission documents.
• Prepare and approve informed consent forms.
• Review regulations and develop solutions to start-up issues.

Conhecimentos

Regulatory submissions management

Clinical Trial Applications knowledge

Strong oral and written communication skills

Leadership skills

Team-oriented approach

Descrição da oferta de emprego

Overview

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 Sao Paulo! 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). 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 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.