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Training and Compliance Specialist (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support, Design
Projektbeschreibung
- Supports the oversight of compliance of all Global Clinical Operations associates worldwide with relevant Business, Legal and Regulatory requirements
- Work with different managers and trainers to define applicabilities of mandatory processes and SOPs
- Participate in training curriculum review
- Track compliance with required training and other regulatory compliance ( code of conduct, SOPs, GCP, protocol training..)
- Review training compliance reports prepared with Development Quality Training
- Participate in the design and organization of global training programmes
- Ensure that a system is in place to track deviations from global SOPs in HQ sites
- Provide assessment of Global Clinical Operations activities
- Support compliance and process improvement initiatives
- Coordinate input to SOP reviews and updates needed for periodic reviews or process changes
- Maintain an overview of applicable SOPs and processes for all Global Clinical Operations roles
- Support the development of on-going quality assessments and self-inspections
- Support implementation and tracking of related CAPAs and commitments
- BS and/or advanced degree in scientific discipline or life science background with stong experience
- Good knowledge of drug development / clinical trials processes
- Good understanding of GCP requirements and quality systems
- Analytical skills
- Good written and verbal communication skills
- Able to work in a multidisciplinary/global environment
- Fluent in oral and written English
Weitere Qualifikationen: Compliance manager
- Work with different managers and trainers to define applicabilities of mandatory processes and SOPs
- Participate in training curriculum review
- Track compliance with required training and other regulatory compliance ( code of conduct, SOPs, GCP, protocol training..)
- Review training compliance reports prepared with Development Quality Training
- Participate in the design and organization of global training programmes
- Ensure that a system is in place to track deviations from global SOPs in HQ sites
- Provide assessment of Global Clinical Operations activities
- Support compliance and process improvement initiatives
- Coordinate input to SOP reviews and updates needed for periodic reviews or process changes
- Maintain an overview of applicable SOPs and processes for all Global Clinical Operations roles
- Support the development of on-going quality assessments and self-inspections
- Support implementation and tracking of related CAPAs and commitments
- BS and/or advanced degree in scientific discipline or life science background with stong experience
- Good knowledge of drug development / clinical trials processes
- Good understanding of GCP requirements and quality systems
- Analytical skills
- Good written and verbal communication skills
- Able to work in a multidisciplinary/global environment
- Fluent in oral and written English
Weitere Qualifikationen: Compliance manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges