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Associate Director/Director
Clinical Compliance
Confirmed live in the last 24 hours
Dorchester, Boston, MA, USA
Experience Level
Desired Skills
Quality Assurance (QA)
  • Bachelor's degree in a life science or allied health field (e.g. nursing, medical or laboratory technology)
  • At least 10 years of experience in clinical research with direct clinical compliance oversight
  • Excellent written and oral communication skills
  • Advanced working knowledge of GCP/ICH and other applicable regulations/guidelines
  • Good organizational skills for the management of clinical development compliance and working in a fast-paced environment
  • Proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and Egnyte)
  • Collaborate with Clinical Development to ensure all trials are conducted in compliance with global regulations, ICH/GCP and applicable business processes and practices
  • Review work and workflows of teams to ensure clinical compliance and provide guidance on training or improvement in processes
  • Keep current with regulatory developments across industry as well as evolving compliance best practices
  • Ensures an effective training program is maintained for all required compliance/regulatory training
  • Collaborate with client stakeholders to answer compliance questions or direct compliance issues to appropriate subject matter experts
  • Ensure that compliance issues associated with clinical audits are properly evaluated and adequately addressed in collaboration with Clinical QA
  • Coordinate assessments of line functions to ensure adherence to stated policies/standards and lead associated work streams as needed
  • Track and report on KRIs/KQIs for Clinical Development
  • Additional duties and responsibilities as required
Tango Therapeutics

51-200 employees