Senior 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 6,000 people across 40+ countries.

Responsibilities:

* Line manage, mentor and develop a team of clinical safety professionals;
* Train and develop more junior Clinical Safety Managers;
* 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;

* Propose and develop specifications for new projects and work directly with client to negotiate them.

Qualifications:

* Bachelor's degree and 5 years of clinical research job experience, including line management experience;

* Ability to lead Clinical Safety activities for multiple large programs;
* Ability to assist in business development activities such as presentations to prospective Sponsors, participation in Sponsor audits, and generation of scope of work and cost estimates.
* Prior project management experience is preferred;
* Demonstrated ability to write departmental SOPs; and
* Bilingual Japanese and English
			

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