Study Start Up Manager
Chicopee, MAFull-time
Behavioral Health Market Context
Apply Nowvia Nexxt
Benefits
Health InsurancePaid Time Off
Job Description
n 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
• Minimum education required is a bachelor's degree completed in a life science major;
• 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.
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
• Minimum education required is a bachelor's degree completed in a life science major;
• 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.
Qualifications
- •Minimum education required is a bachelor's degree completed in a life science major;
- •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
- •Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
Benefits
- •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
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
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