Clinical Process Excellence Specialist
4300 Hacienda Drive Pleasanton, CA 94588
Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.
- Supports the Head of Clinical Process Excellence in process and continuous improvement, harmonization, regulatory compliance, training, and inspection readiness activities across COBM.
- Provides logistical and technical support and expertise for audits and inspections involving COBM.
- Reviews study documentation to help ensure compliance with standard operating procedures and applicable regulations.
- Collaborates with key stakeholders and acts as a change agent in support of the process improvement activities across COBM.
- Performs quality checks on work executed on behalf of Log-In; for example: training material, deployments of training, role-based training matrices, metrics reporting, and communications.
- Contributes to innovative sustainable solutions in support of establishing a standardized approach and oversight of best practices.
- Perform needs assessments and track trends to support the quality continuous improvement strategy.
- Provides assistance with training programs across required geographic locations and applicable technologies, including, but not limited to assistance with: training material, trainer and trainee schedules, event logistics, delivering trainings, documentation, and feedback, as applicable.
- Other duties as assigned by manager.
- Working knowledge of Quality and best practices.
- Attention to detail and a process
- Strong results orientation and change
- Strong stakeholder management
- Excellent communication, facilitation and interpersonal skills
- Ability to achieve results in a quality or operational
- Knowledge / expertise in the science and technical aspects of applicable Roche instruments and assays
- BS/BA in technical/scientific field or technical experience
- At least 2 years of relevant experience in Clinical Operations, Biometrics, Quality, or related field