Sr. Materials Manager
Marlborough, MA | Contract
The Sr. Manager, CTM Management, is responsible for co-leading, executing and refining strategies and standards in Clinical Inventory Management System that operates based on Smart Supplies PMD and RAR platforms. The Sr. Manager CTM Management and Technology is also responsible for conducting, and leading, activities and operations of CTM supply prepared and delivered on demand to study subjects in complex clinical studies worldwide. CTM Management competencies include Forecasting and Planning, Inventory Management, Packaging and Labeling, Global Distribution, IRT Technology, Outsourcing Management, Capacity and Performance Metric, Project Management, and Conformance of Quality and Compliance requirements.
1. Coordinate team efforts internally and externally in maintenance and upgrading Clinical Inventory Management System (CIMS) that is based on Smart Supplies PMD and RAR platforms. Responsible for leading, executing and refining organizational strategies and standards in ClMS.
2. Support CTMM specialist for CIMS in operating the system and providing protocol level support from start up, study maintenance to study close out; and providing documented training for all users worldwide.
3. Lead the execution of system upgrade and interface with CTMS and other external system.
4. Provide higher level of troubleshooting in CIMS, identify gaps and implement improvements to ensure data accuracy and user support to meet evolving business needs, manage the system access, integrity, interfaces and the upgrade of the system.
5. 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.
6. Manage distribution/logistics activities of complex supply chains by evaluating supply strategies, tracking inventories, tracking expiry dates, initiating bulk shipments, coordinating import/export requirements. Coordinate set up/planning/end-user testing/ of Interactive Response Technology (IRT, e.g. IVRS, IWR) in line with study needs. Ensure integrity of all clinical supply chain management databases used for managing clinical trial meet requirements
7. Manage operating budgets for sourced services and activities. Lead initiatives for generation, refinement and maintenance of clinical supply infrastructure and cross-functional collaboration. Comply with ICH, Federal U.S. and any pertinent local regulations and adhere to Sepracor SOP and Guidance Documents.
Education level and/or relevant experience(s):
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
Knowledge and skills (general and technical):
• Experiences in Smart Supplies PMD and RAR are preferred.
• Leadership skills that motivate and energize a group or an individual for peak performance
• Ability to comprehend and respond to complex problems and with effective problem-solving
• Excellent verbal and written communication skill and ability to lead and to work with a team consisting of a broad range cross-functional areas internally and externally
• 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 steps 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 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
• Proficient Microsoft Office skills and knowledge of Interactive Response Technology and databases.
Familar with ERP system user acceptance testing and validation requirements
All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of the clientare carried out with the "best" industry practices and the highest ethical standards.
Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.