Regulatory Submissions (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 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:

* More than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
* Regional experience will be highly advantageous;
* Strong oral and written communication skills.

Travel: Minimal, with potentially hybrid working arrangements based on eligibility.
			

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