Clinical Safety 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:

* Line manage, mentor and develop a team of clinical safety professionals;
* Manage relationships with clients and internal stakeholders by providing expert safety knowledge;

* Oversee clinical safety case management and aggregate reporting responsibilities of direct reports to ensure client needs are fulfilled to high quality;

* Create safety management plans dependent upon client;

* Provide safety review of clinical study documents, including protocols, study reports; and marketing application components

Qualifications:

* BSN or equivalent healthcare experience with a bachelor's degree;

* At least 4 years of clinical research/pharmacovigilance experience;

* At least one year of clinical nursing experience; and

* Prior project management experience is preferred.
			

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