Senior Compliance Specialist

Skills
Analytical SkillsContinuous ImprovementEasily AdaptableGood Clinical PracticeGoogle Cloud PlatformIdentifying TrendsProcedural
Role

What the job involves

The main requirements, responsibilities and hiring steps.

Requirements

  • Bachelor's degree or equivalent combination of education training and experience
  • 4+ years of relevant experience or equivalent combination
  • Comprehensive knowledge of ICH GCP and applicable clinical research regulations
  • Proven project management experience in clinical trial delivery and cross-functional initiatives
  • Extensive knowledge of the clinical trial process
  • Excellent oral and written communication skills
  • Strong organizational and time-management skills
  • Demonstrated problem-solving and analytical skills
  • Excellent attention to detail
  • Strong computer skills and ability to learn new software quickly
  • Ability to work independently and collaborate effectively
  • Experience mentoring colleagues and leading process improvement initiatives

Nice to have

  • Analytical Skills
  • Continuous Improvement
  • Easily Adaptable
  • Identifying Trends
  • Procedural

Day to day

  • Lead quality and compliance processes to ensure activities are completed on time and meet high standards.
  • Research and resolve compliance issues while tracking metrics maintaining reports and managing documentation.
  • Coordinate with cross-functional teams on audits CAPA procedural documentation and improvement initiatives to strengthen operations.