Clinical Supply Manager

Responsibilities:

  • Working with company’s contract manufacturing organizations to ensure:
    • Clinical labeling, packaging and distribution needs for Cara’s clinical trials occur in a timely and cost-effective manner
      • In collaboration with Cara Quality Assurance and vendors, create/review labeling and packaging protocols and packaging records
      • Review/approve distribution protocol
  • Working with CMC Department to ensure adequate supplies are available
    • Manage total inventory and inventory for each clinical trial
    • Ensure return of supplies at the end of each study
  • Partnering with Clinical Team and Clinical Research Organizations to assist in IVRS/IWRS (or other IRT) development and implementation
  • Working with Quality Assurance and Regulatory Affairs to identify, communicate and resolve potential quality issues arising during clinical trials

Requirements:

  • A Life Sciences graduate degree preferred with a minimum of 5 years of experience in supply chain management in a pharmaceutical or biotech environment.
  • Experience with management of clinical supplies (Phase 1-3) for concurrent clinical trials
  • Experience with import/export and cold chain desirable
  • Experience working with contract manufacturing organizations
  • Working knowledge of appropriate parts of 21CFR, 210-211
  • Effective communication skills
  • Demonstrated problem-solving ability
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