Description:

Candidate must have demonstrated expertise in performing the activities required to support ongoing clinical trials and the ability to independently manage the clinical supply function, including liaising with cross-functional teams and managing vendors (e.g. label, packaging and distribution).Candidate should have a working knowledge of the ICH guidelines, GCPs, GMPs, CFRs, and SOPs

Responsibilities:

• Forecast clinical supply needs and develop clinical supply strategies in collaboration with Clinical Operations. • Work with Supply Chain/R&D staff to ensure that bulk supply is available when needed. • Contribute to labeling and packaging strategy and manage label approvals. • Manage and track the clinical supply inventory for all assigned trials. • Identify/select appropriate vendors/suppliers through comparisons on services, pricing, location, etc. • Manage labeling and packaging activities at vendors, including reviewing and approving labels, master batch records and executed batch records • Manage budget, purchase orders, and invoices for clinical supply activities. • Develop/expand and maintain tools to facilitate clinical supply management, communicate changes, evaluate impact of changes and report to management and staff. • Collect and organize clinical supply documentation for the Trial Master File. • Develop and maintain Standard Operating Procedures related to clinical supply, and participate in the development and review of departmental Standard Operating Procedures

Requirements:

BS/MS, BA, RN, BSN, or R. Ph. in Health or Biological Sciences or related field with 3+ years experience in clinical supply chain management Ability to participate in the development and review of Standard Operating Procedures Must have knowledge of ICH guidelines, GCPs, GMPs and CFRs. Knowledge of the infrastructure and operational characteristics of vendors

Candidates must live local and be a US Citizen or Green Card Holder

 Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

 www.cwsciences.com