Clinical Trial Project Manager

AR-Ciudad Autonoma de Buenos Aires

International Careers

Req #: 10515
Type: Full-Time
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Medpace, Inc.

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				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:

* Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations
* Serve as primary Sponsor contact for operational project-specific issues and study deliverables
* Maintain in depth knowledge of protocol, therapeutic area, and indication
* Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided
* Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable
* Develop operational project plans
* Manage risk assessment and execution
* Responsible for management of study vendor
* Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables

Qualifications:

*We kindly ask to send applications in English.

* Bachelor's degree in a health-related field; Advanced degree in a health-related field preferred
* Experience in Phases 1-4; Phases 2-3 preferred
* 5+ years as a project/clinical trial manager within a CRO
* Management of overall project timeline
* Bid defense experience, preferred 
* Strong leadership skills
* Fluency in English
			
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