Clinical Supplies Project Manager

Nextrials, Inc. is a leading healthcare intelligence and clinical research organization. They are seeking a Clinical Supplies Project Manager to provide scientific and technical support for projects involving Pharmaceutical Supply Management and Clinical Supplies activities, managing global pharmaceutical supply for clinical studies.

Responsibilities:

• Help to develop drug supply planning strategy and overall management of supplies for clinical studies
• Generates initial and revises drug forecast at study and program level, communicating demand requirements to CMC and other stakeholders
• Coordinates the procurement activities for comparator and NIMP and/or ancillary supplies
• Interprets relevant protocol information to develop packaging/labeling design for clinical supplies
• Establishes distribution strategy and manages packaging/distribution timelines
• Supports design and set-up of IRT system
• Coordinates the origination, proofing and transition of clinical study labels
• Proactively communicates drug supply delivery timelines to appropriate stakeholders
• Coordinates the required documentation and activities for import and export of clinical supplies
• Monitors global inventory and proactively communicates with all stakeholders to ensure adequate quantity and timely delivery of clinical supplies throughout duration of a trial
• Monitors and manages retest dating for assigned study supplies
• Proactively identifies potential risks, provides corrective plans, and resolves clinical supply issues and complaints
• Provides information to support financial planning for global studies and monitors drug supply study budget
• Reviews new proposal requests and determines required clinical supplies management support
• Provides responses to potential new client request for information related to clinical supplies management

Requirements:

• Bachelor degree required
• Drug Forecasting (Off the protocol preferred) or Demand Planning experience required
• 3 plus years of prior experience in a pharmaceutical, biotech and clinical supply logistics environment preferred
• Strong experience and skills in the management of clinical supply chain logistics
• Knowledge of regulations governing investigational products, including GMP and ICH/GCP guidelines
• Knowledge of project management and Clinical customer relationship building
• Advanced degree nice to have
• Cell and Gene Therapy expertise preferred