Clinical Trial Manager - Oncology

				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:

The Clinical Trial Manager (CTM) position performs as project lead for multiservice clinical trials (some global in scope).  The position interacts with sponsors and manages the timeline and all project deliverables.  This role coordinates all services contracted for the study.  CTMs are also responsible for leading a team of CRAs and managing project coordinators. 

* 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;
* Manage study vendors where applicable; and
* Manage site quality and monitoring deliverables.

Qualifications:

* Bachelor's degree or above in health/life science related field;
* At least two years of clinical trial management experience in the Asia Pacific region; indications of interest a plus
* Prior CRO experience is preferred
* Excellent communication skills including good verbal and written English; and
* Flexible, accountable, and comfortable working in a global environment.
			

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