Director of Clinical Operations
Compliance and Oversight
Confirmed live in the last 24 hours
Cambridge, MA, USA
Experience Level
Desired Skills
  • Bachelor's degree required. Master's degree in Clinical Sciences, Public Health, Healthcare Administration highly preferred
  • Minimum of 8 years of experience in clinical research with at least 6 years of direct responsibility and experience in a clinical compliance role,or mixed with trial management lead responsibilities
  • Excellent written and oral communication skills exemplified by timely follow-up; meeting participation; effective negotiating skills; the ability to summarize and frame issues, discussions, conclusions; and development of effective communication plans
  • Advanced working knowledge of GCP/ICH/TMF and other applicable regulations/guidelines
  • Ability to manage multiple projects in a fast-paced environment
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment
  • Evaluate, write and/or revise relevant standard operating procedures and work instructions
  • Lead inspection readiness planning and activities
  • Lead TMF oversight efforts, by establishing standard process for oversight and compliance checks to established process
  • Collaborate cross functionally to evaluate and develop strategic action plans to ensure compliance and oversight with clear and measurable outcomes/key quality indicators
  • Liaison with study teams and outsourced partners/ vendors to establish/refine standard reporting
  • Design and implement vendor and documentation oversight procedures and effectiveness checks
  • Partner with Clinical Quality Assurance to action and respond to internal audits, CAPAs and effectiveness checks
  • Identification of gaps/risks in process, procedures and proactively planning solutions and actions to mitigate gaps or risks
Editas Medicine

51-200 employees