JVT Advisors

Clinical Trial Manager

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Location: Marlborough, Massachusetts 01752
Employment Type: Contract

Job Description

Contract Length: 6 months

Job Summary: This person will co-lead, execute and refine strategies and standards in a Clinical Inventory Management System that operates based on Smart Supplies PMD and RAR platforms. Will also be responsible also be 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.

Responsibilities:

  • 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. Responsible for leading, executing and refining organizational strategies and standards in ClMS.
  • 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.
  • Lead the execution of system upgrade and interface with CTMS and other external system.

Requirements:

  • 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.
  • Working knowledge and understanding of GMP, GCP, GDP, and relevant ICH and FDA guidelines.
  • Working knowledge of supply and distribution operation
  • Working knowledge of Clinical Trial Materials development, manufacturing, packaging and labeling
  • Proficient Microsoft Office skills and knowledge of Interactive Response Technology and databases.

 

Michael Liuzza

Senior Recruiter

As a Senior Recruiter, Michael Liuzza brings almost a decade of sourcing and hiring experience to the JVT team. In his current role, Michael is responsible for full lifecycle recruiting, partnering with JVT's Contract Recruiting Team to match superior available talent with career building opportunities.

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