Clinical Supply Chain Consultant

To meet client needs, DSI is seeking a Clinical Supply Chain Consultant to expand our growing team.LEARN MORE

Role and Responsibilities

In this position the supply chain consultant will support clients in a variety of ways:

  • Understanding of clinical study protocols as it applies to CTM demand and forecasting
  • Understanding of typical clinical trial designs that affect patient supply including open label, blinded and double dummy studies, as well as complex drug packaging such as titration studies, childproofing, multi strength packs, etc.
  • Understanding of design of various types of clinical labels and required text for US and EU
  • Source and management of CTM packaging and labeling including RFP’s, CMO bid review and recommendation, review of CMO packaging and labeling contracts, tech transfer and startup
  • Forecast and manage CTM supply chain including API, bulk & packaged drug supply
  • Understanding of IVRS, CTM site supply control and resupply
  • Create, maintain and manage high level production schedules
  • Manage packaging/shipping per schedules
  • Manage domestic and international raw material shipments and finished goods
  • Manage CTM expiration and expiration date extension
  • Maintain relationships and negotiate contracts with suppliers

Qualifications and Education Requirements

  • Candidates must have a minimum of 5-7 years of practical experience in clinical supply chain management with direct experience in the management of CMO distribution activities
  • Negotiating skills a plus
  • B.S. in the sciences

Prefered Skills

  • Familiarity with production forecasts and forecast models
  • Demonstrate ability to establish strong vendor relationships on behalf of clients
  • Direct experience in the management of clinical trial material distribution
  • Ability to manage cross-functional, multi-national teams
  • Knowledge cGMPs and relevant FDA Regulations essential
  • Proficient in Microsoft Project, Excel, PowerPoint and Word is a plus

Location

    Remote/Virtual

Position Type

    Sub-Contractor

Travel Requirements

    Required Travel Up to 25% if directed by a client