Clinical Trial Operations Manager

3 days ago


Cincinnati Ohio, United States Medpace, Inc. Full time
Job Summary

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 Operations Manager to join our Clinical Trial Management Group in Cincinnati, OH.

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, 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.
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.
About Medpace, Inc.

Medpace, Inc. is a full-service 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.

Why Medpace, Inc.?

At Medpace, Inc., we are committed to making a difference in the lives of patients and families affected by disease. We offer a dynamic and supportive work environment, with opportunities for professional growth and development. Our team members are passionate about delivering high-quality results and making a positive impact on the world.



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