Work Environment:

*** This is a hybrid position based onsite at any of the posted locations with a minimum of 3 days onsite weekly.  Relocation and mobility assistance are not provided.

Main Responsibilities:

• Ensure efficient, cost-effective clinical trial supply planning and management for low to medium complexity studies

• Performs planning and forecasting of drug volume requirements

• Sample collection and analysis

• Ensures proper storage, transportation and archiving

• Assists with selection and management of external service providers in compliance with outsourcing strategy to ensure cost efficient and high quality services

• Leverages interactive response technology (IRT) system to support clinical supply management activities

• Authors/reviews critical study documents (e.g. study protocol, product dossiers, handling instructions, study reports)

• Leads or participates in global Clinical Trial Supply project meetings with internal and external team members

• Partners with R&D and other functions to ensure optimal use of systems and processes to support clinical trial supply chain

• Supports continuous improvements in clinical drug supply and revises SOPs to ensure ongoing compliance and efficient conduct of clinical trial supply activities

Minimum Qualifications:

• Bachelors Degree in Life Sciences, Engineering, Logistics or equivalent experience

• 5+ years of experience in clinical supply management with the pharmaceutical industry

• Demonstrated knowledge of ICH-GCP regulations and the conduct of clinical studies

• Demonstrated knowledge of cGMP and cGDP regulations

• Team-player with proven effective interpersonal and communication skills