Functional Process Owner Emr2edc Global Clinical Solutions Technologies
Trzdev7
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Extensive experience in drug development
Strong operational knowledge of system processes
Experience with medidata rave configuration
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Trzdev7 is seeking a Functional Process Owner for their Emr2edc Global Clinical Solutions Technologies division. This role involves overseeing the lifecycle of development operations system processes, requiring extensive experience in drug development and strong project management skills.
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Job Summary
The role involves owning the full lifecycle of Development Operations system processes from design to continuous improvement within a global clinical solutions context.
Candidates must provide expert advice, training, and support on system processes while defining and tracking KPIs for allocated processes.
The position requires extensive experience in drug development and strong operational knowledge of system processes specifically in the clinical trial setting.
Matching Summary
Match Score: 75
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Trzdev7 is seeking a Functional Process Owner for their Emr2edc Global Clinical Solutions Technologies division. This role involves overseeing the lifecycle of development operations system processes, requiring extensive experience in drug development and strong project management skills.
**
Skills & Requirements
Must-have
Extensive experience in Drug Development
Strong operational knowledge of system processes
Experience with Medidata Rave configuration
Knowledge of ICH/GCP regulations
Validation of computerized systems in regulated environment
Nice-to-have
Lean Six Sigma process improvement methodology
Recognized expert reputation within the industry
Experience planning EMR2EDC middleware systems
Strong vendor management capabilities
Creative and innovative problem-solving skills
Key Requirements
Bachelor of Science (BSc) in relevant discipline
Extensive pharmaceutical or clinical environment experience
Comprehensive knowledge of ICH/GCP standards
Proven track record in project management delivery
Experience with GxP, SOX, and related requirements