Medpace: Clinical Trial Management (Europe) - Anonymised Webinar Event For Experienced CTM's
FR-Lyon
International Careers
Req #: 11403
Type: Full-Time
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Overview: Medpace is a full-service clinical contract research organisation (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: Clinical Trial Manager: * Manage and provide accountability for day-to-day operations of the studies conducted by Medpace on behalf of Biotech sponsors, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, SOPs 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 * Lead internal project team and Provide cross-functional oversight of study team deliverables. * Review and provide input for study protocol, database edit check specifications and final study report, when applicable * Develop study-specific operational project plans * Implement and manage a risk-based approach to project execution * Responsible for management of study vendors * Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables, including CRA trip report review Qualifications: * Bachelor's degree in a health or life science-related field; Advanced degree in a health or life science-related field preferred; * Experience in Phases 1-4; Phases 2-3 preferred; * Minimum of 5 years of Clinical Trial Management experience, CRO experience preferred; * 5+ years of Project Manager/Clinical Trial Manager experience at a CRO required; * Management of overall project timeline; * Bid defense experience preferred; and * Strong leadership skills.
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