Job Summary
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Medpace, Inc. is a leading contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. We are seeking an experienced Clinical Trial Project Manager to join our Clinical Trial Management Group in Sao Paulo, Brazil.
We offer a dynamic work environment with remote flexibility and opportunities for professional growth. Our therapeutic areas of focus include Oncology, Cardiovascular/Metabolic, Infectious Disease, CNS, and more.
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, including 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:
* 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; required for home-based.
* Management of overall project timeline.
* Strong leadership skills.
* Fluency in English.