Clinical Trial Project Manager

4 weeks ago

Cincinnati, Ohio, United States Medpace Full time
Clinical Trial Project Manager Job Summary

Medpace is seeking a highly skilled Clinical Trial Project Manager to lead full-service global clinical trials for Medical Devices. The ideal candidate will have experience in Medical Devices, specifically in Metabolic, Cardiovascular, Diabetes, and other areas. As a project lead, you will interact with sponsors, manage timelines, and oversee project deliverables. If you are passionate about delivering effective collaboration, training, and resource planning globally to accelerate the development of safe and effective medical therapeutics, this opportunity is for you.

Key Responsibilities:
  • Lead a clinical team, providing daily work direction to clinical study team members to support clinical site needs and meet sponsor goals and timelines.
  • Coordinate and manage project start-up, maintenance, and close-out activities.
  • Maintain ongoing sponsor contact for project-specific issues, serving as the primary contact for sponsors and project team members.
  • Track study status and progress according to milestones, identify potential issues or challenges, and work with the team to develop 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 plans, clinical monitoring plans, patient recruitment and retention plans, and other study-specific documents and management tools.
  • Communicate changes in scope to sponsor clinical teams and Medpace Account Managers.
  • May be responsible for other projects and responsibilities as assigned.
  • Provide input on study protocols, clinical investigation plans, edit check specifications, data analysis plans, data clean-up results, analysis, and final study reports.
Requirements:
  • Bachelor's degree in Life Sciences or a related field, with a minimum of 3 years of related medical device industry experience, or a Master's degree in Life Sciences or a related field, with a minimum of 2 years of related medical device industry experience.
  • Prior experience with medical device trials is preferred.
  • CRO experience is preferred.
  • Exceptional communication skills (oral and written).
  • High attention to detail and quality standards.
  • 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.
  • Proficient with all Microsoft Office applications (Word, Excel, PowerPoint, Project, etc.).
About Medpace:

Medpace is a full-service clinical contract research organization (CRO) providing 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 our 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 over 5,000 people across 40+ countries.

Why Medpace?

At Medpace, we value our people, purpose, and passion. We strive to make a difference in the lives of patients and families affected by disease. Join us today and be part of a team that accelerates the development of safe and effective medical therapeutics.

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