Study Start-Up Project Manager-Remote

				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 successful execution of global start-up, maintenance, and close-out studies;
* Effectively lead others in a matrix environment;
* Perform quality checks on submission documents and site essential documents;
* Prepare and approve informed consent forms;
* Serve as a Sponsor point of contact for start-up and regulatory submissions items;
* Review pertinent regulations to develop proactive solutions to start-up challenges; 
* Prepare new business proposals and present during bid defenses, general capabilities meetings, and audits;
* Contribute to the growth and development of departmental staff, processes and systems.

Qualifications:

* Bachelor's degree required, advanced degree in Life Sciences preferred
* 5+ years of experience in clinical research, preferably in a Senior/Lead role at a CRO in Study Start-Up
* Project management experience and demonstrated role in developing others
* Strong oral and written communication skills required

Travel: Minimal
			

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