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Clinical Supply CTM Management needs 10 years in-line experience in clinical supply management, and Enterprise Resource Planning
Clinical Supply CTM Management requires:
 B.S. / M.S / PhD in Science or Engineering with 10 years in Enterprise Resource Planning experience and 5+ years in line experience in clinical supply management
 Strong computer science and engineering knowledge with system building experience.
- knowledge of global clinical development end-to-end process
- knowledge of developing and managing an interactive enterprise system for managing resource or assets.
- Able to step up to conflicts, seeing them as opportunities; reads situations quickly and can find common ground and get cooperation with minimum noise.
- Working knowledge and understanding of GMP, GCP, GDP, and relevant ICH and FDA guidelines.
- Working knowledge of global supply and distribution operation
-Working knowledge of establish and managing partnership with CMO and CRO
- Working knowledge of Clinical Trial Materials development, manufacturing, packaging and labeling
- Strong project management skill and leadership skill.
- Proficient Microsoft Office skills and knowledge of Interactive Response Technology and databases.
Other requirements (licenses, certifications, specialized training, and physical or mental abilities required):
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Clinical Supply CTM Management duties:
• Participate in clinical protocol development and interperet protocol into clinical supply needs and strategies supporting clinical study global submissions and execution.
• Aggregate and quantify future requirements for clinical trial materials into a comprehensive supply/demand forecast.
• Conduct capacity planning to create a supply plan for all phases including complex phase III studies or dose flex adaptive studies.
• Design and develop packaging, label text and labeling fit for purpose and in compliance with local regulatory requirements. Manage packaging and labeling activities.
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