Clinical Trial 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:

* Effective Management of a project including:
* Coordinate and manage project start-up, project maintenance, and project close-out activities;
* Maintain ongoing Sponsor contact for project-specific issues by serving as primary contact for Sponsor and all project team members;
* Track study status including patient status, Case Report Form status, safety issues, timelines, etc.;
* Serve as primary contact for protocol interpretations and logistical project-related issues (internal and external);
* Provide management oversight for Clinical Research Associates and Project Coordinators on project team;
* Interpret contract-related issues and coordinate Medpace activities according to current scope;
* Develop study management tools, including communication plan, clinical monitoring plan, patient recruitment and retention plan;
* Communicate change in scope to Sponsor clinical team and Medpace Contract Manager.

* Provide input for following (when applicable):
* Study protocol
* Edit Check Specifications
* Data Analysis Plan
* Data clean-up results
* Analysis
* Final study report

Qualifications:

* Bachelor's degree and 4 years related pharmaceutical industry experience (clinical monitoring or study management), or Master's degree/PhD with 2 years of related pharmaceutical industry experience (clinical monitoring or study management);
* Broad knowledge of medical terminology, clinical patient management, and clinical research methodology;
* Bilingual Japanese and English
			

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Medpace, Inc.

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