Senior Manager of Clinical Trial Materials
A global Pharmaceutical corporation specializing in innovative psychiatric, neurological and respiratory therapies is seeking to hire a Senior Manager of Clinical Trial Materials for their NJ/NY Metro area location.
The Senior Manager of Clinical Trial Materials will be responsible for: 1) Conducting, and leading, activities and operations of CTM supply prepared and delivered on demand to study subjects in complex clinical studies worldwide. 2) Coordinate team efforts internally and externally in maintenance and upgrading the company's Clinical Inventory Management System (CIMS) that is based on Smart Supplies PMD and RAR platforms. 3) 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. 4) Manage distribution/logistics activities of complex supply chains by evaluating supply strategies, tracking inventories, tracking expiry dates, initiating bulk shipments, coordinating import/export requirements. 5) 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.
Title: Sr. Manager, Clinical Trial Materials
Location: Fort Lee, New Jersey
Pay Range: $85-90
- Must have at least 10 years of Enterprise Resource Planning and 5 years of clinical supply management experience
- Education Requirement: minimum of a Bachelor's degree in Science of Engineering
- Experience in Smart Supplies PMD and RAR are preferred.
- Must have experience in the following: Global clinical development end-to-end process, supply and distribution operation and working knowledge of establishing and managing partnerships with CMO and CRO.
- He/she should have 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.
- Working knowledge and understanding of GMP, GCP, GDP, and relevant ICH and FDA guidelines.
- Working knowledge of Clinical Trial Materials development, manufacturing, packaging and labelling.
Sthree US is acting as an Employment Business in relation to this vacancy.