Clinical Trial Manager

  •  

Cincinnati, OH

Industry: Business Services

  •  

Less than 5 years

Posted 62 days ago

  by    Moe Viloria

This job is no longer available.

Our client is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. The client's mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.

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
  • 3-5 years in project management/clinical trial management in clinical research industry
  • Strong leadership skills

Salary

$120K - $140K