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121201 F. Hoffmann-La Roche AG

Global Clinical Operations Excellence Lead - Study Systems Lead(m/w/x)

Basel
Full-timeOn-siteSenior
AI/ML

Implementing program-wide study systems (IRT, eCOA) for clinical trials at patient-focused biotech. Comprehensive clinical trials infrastructure knowledge with ICH/GCP regulatory guidelines required. High autonomy in driving system improvements.

Requirements

  • Established professional with comprehensive working knowledge of clinical trials infrastructure
  • Proven experience in clinical trial operations, compliance, audit, inspections, vendor management, systems, or learning
  • Demonstrated subject matter expertise in clinical operations infrastructure activities
  • Proficient knowledge of ICH, GCP, and regulatory guidelines in clinical trials
  • Ability to independently prioritize work and influence team plans
  • Skilled in solving complex outcomes and analyzing multiple information sources
  • Experience in mentoring and coaching less experienced colleagues

Tasks

  • Lead continuous improvement and change management activities
  • Implement program-wide study systems like IRT and eCOA
  • Oversee process management and monitor performance
  • Apply expertise in Quality, Compliance, Business Process, or Knowledge Management
  • Collaborate globally with Quality and research teams
  • Optimize processes to ensure quality and compliance
  • Drive adoption of innovative technologies and AI
  • Promote new ways of working and enhance operational efficiency
  • Ensure GCP/GVP compliance and data integrity
  • Mentor and coach colleagues in clinical operations
  • Lead parts of global infrastructure projects

Work Experience

  • approx. 4 - 6 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent
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