Menu +

Clinical Trial Manager

The Clinical Trial Manager (CTM) will manage all clinical aspects of a study.

Responsibilities:

  • Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements
  • Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents
  • Develop study budget and timelines
  • Prepare regulatory documents and submissions
  • Maintain Trial Master File
  • Manage Investigational Product (IP)
  • Manage safety reporting
  • Procure and manage contracts with CROs, study vendors and investigative sites
  • Provide oversight of CROs, independent field monitors and other clinical vendors
  • Review monitoring trip reports and track resolution of all action items
  • Co-monitor at investigative sites to evaluate study site and field monitor performance
  • Collaborate with medical experts

Requirements:

  • Minimum BS / BA (science or health care field) or nursing degree
  • 6 or more years’ experience as a CRA or field monitor at in a pharma or CRO setting

Preferred Skills, Qualifications, or Technical Proficiencies:

  • Attention to detail and ability to prioritize tasks to meet critical deadlines
  • Excellent verbal and written communication skills
  • Able to collaborate effectively with the study team, cross-functional team members, and external partners
  • Knowledge of ICH/GCP and FDA regulations
  • Strong proficiency in Microsoft Office

    If you are interested, please submit your resume by email to hr@corcept.com

built@zoomedia
You are now leaving this website. If you would like to continue, click Continue.
Cancel Continue