Study Start Up Manager

				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.

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
			

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