Shire Jobs

Clinical Trial Project Manager (Medical Device) Job Locations United States-OH-Cincinnati Category Clinical Trial Management Job Summary Medpace is seeking a Clinical Trial Manager to act as project lead for full service global clinical trials for Medical Devices. We are looking for experience within Medical Devices for Metabolic, Cardiovascular, Diabetes, and more. The position interacts with sponsors and manages the timeline and all project deliverables. Are you interested in delivering effective, end-to-end collaboration, training, and resource planning around the globe to accelerate the global development of safe and effective medical therapeutics? If so, this opportunity is for you. Responsibilities Lead clinical team providing daily work direction to clinical study team members to support needs of clinical site, and work to meet goals and timelines of Sponsor, including determining study objectives, strategy, scope, and schedule to meet Sponsor's needs; Coordinate and manage project start-up, project maintenance, and project close-out activities; Maintain ongoing Sponsor contact for project-specific issues by serving as primary contact for Sponsor and all project team members; Track study status and progress according to milestones, identify and anticipate potential issues or challenges, and work with team to develop appropriate solutions; Provide project management oversight of Project Coordinators, Clinical Trial Assistants, Clinical Research Associates and other clinical study team members; Develop Study management tools, including communication plan, Clinical Monitoring Plan, patient recruitment and -retention plan, and other study-specific documents -and management tools; Communicate change in scope to Sponsor clinical team and Medpace Account Manager; May be responsible for other projects and responsibilities as assigned; and Provide input on the following (as applicable): Study protocol/Clinical Investigation Plan Edit check specifications Data analysis plan Data clean-up results Analysis Final study report Qualifications Bachelor's degree in Life Sciences or related field and a minimum of 3 years of related medical device industry experience (i.e. project management), or Master's degree in Life Sciences or related field and minimum 2 years related medical device industry experience Prior experience with medical devices trials is preferred; CRO experience is preferred; Exceptional communication skills (oral and written); High attention to detail and quality standard; Strong time and project management skills; Demonstrate measurable knowledge of Good Clinical Practice for medical device trials in the US (21 CFR 812 and other sections) and/or Europe (ISO 14155), and local regulations; and Proficient with all Microsoft Office applications (Word, Excel, Power Point, Project, etc.). Medpace 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. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key ther