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1201 F. Hoffmann-La Roche AG
last mo.

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

Basel
Full-timeOn-siteSenior
AI/ML

Description

As a Global Clinical Operations Excellence Lead, you will enhance clinical trial delivery by driving improvements, implementing innovative systems, and collaborating across teams. This role focuses on ensuring compliance and leveraging technology to boost efficiency and quality.

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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

Work Experience

approx. 4 - 6 years

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

Languages

English – Business Fluent

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