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Global Clinical Operations Excellence Lead - Study Systems Lead(m/w/x)
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
- English – Business Fluent
Not a perfect match?
- BeOne Medicines I GmbHFull-timeOn-siteManagementBasel
- 1201 F. Hoffmann-La Roche AG
Unit Lead Operation Excellence & Performance Delivery(m/w/x)
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Affiliate Network Regional Quality Lead(m/w/x)
Full-timeOn-siteExperiencedBasel - Roche
Head of Compliance and Quality Governance(m/w/x)
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Global Clinical Operations Excellence Lead - Study Systems Lead(m/w/x)
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
- English – Business Fluent
About the Company
1201 F. Hoffmann-La Roche AG
Industry
Pharmaceuticals
Description
The company focuses on developing innovative products that make a meaningful difference for patients worldwide.
Not a perfect match?
- BeOne Medicines I GmbH
Regional Clinical Compliance Director/ Senior Director(m/w/x)
Full-timeOn-siteManagementBasel - 1201 F. Hoffmann-La Roche AG
Unit Lead Operation Excellence & Performance Delivery(m/w/x)
Full-timeOn-siteSeniorKaiseraugst - 1201 F. Hoffmann-La Roche AG
Global Operations Asset Leader(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Affiliate Network Regional Quality Lead(m/w/x)
Full-timeOn-siteExperiencedBasel - Roche
Head of Compliance and Quality Governance(m/w/x)
Full-timeOn-siteSeniorKaiseraugst