Study Start Up Manager

Medpace; Chile; Presencial; CLP 47.573.000 - 66.604.000; Jornada completa

Descripción de la vacante

A clinical research organization in Chile is seeking a full-time Regulatory Submissions Manager to oversee the study start-up process. The ideal candidate will have at least 4 years of experience in regulatory submissions and strong communication skills. Responsibilities include managing global start-up aspects, quality checks, and developing solutions for regulatory challenges. The role is office-based, requiring fluency in English and a local language, offering a supportive work environment and competitive compensation.

Servicios

Flexible work environment

Competitive compensation and benefits package

PTO packages

Structured career paths

Company-sponsored employee appreciation events

Health and wellness initiatives

Formación

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

Conocimientos

Regulatory submissions management

Clinical Trial Applications

Oral and written communication

Leadership

Team-oriented approach

Fluency in English & local language

Descripción del empleo

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 Chile. 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
• 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
• 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 Americas 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.

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
• Fluency in English & local language

• 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