location_onLondon, UK
watch_later Posted: Nov 23, 2024
Skills Required
Nice To Have skills
Job Description
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.
- 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
- 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 for a remote-based role;
- Management of overall project timeline;
- Bid defense experience preferred; and
- Strong leadership skills.