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Clinical Trial Manager

Job Description:

The Product Manager will contribute to the strategic and tactical marketing responsibilities centered around Korlym’s Cushing's syndrome indication and disease state education. Responsibilities also include pull through and execution of the marketing brand plan, as well as overall life cycle management.


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

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