Clinical Trial Supply Chain Manager

2 weeks ago


Aurora, Colorado, United States CPC Clinical Research Full time
Job Overview

CPC Clinical Research is looking for a dedicated professional to fill the role of Clinical Trial Drug Supply Specialist.

The Clinical Trial Drug Supply Specialist will play a crucial role in overseeing regulatory and investigational product functions essential for our clinical studies. This position entails managing both internal workflows and external partnerships, including Contract Manufacturing Organizations (CMOs), to ensure the supply, labeling, production, and distribution of products adhere to regulatory standards.

Key Responsibilities:

  • Oversee Qualified Person responsibilities and regulatory requirements.
  • Ensure adherence to FDA guidelines and other regulatory bodies.
  • Foster relationships with regulatory organizations.
  • Prepare and file necessary regulatory documentation.
  • Provide regulatory guidance to operational teams.
  • Submit trial-related information to public registries.
  • Coordinate with Institutional Review Boards (IRBs) and Ethics Committees (ECs).
  • Manage all components of investigational product supply for trials.
  • Establish and document supply chain protocols.
  • Monitor stock levels and oversee distribution processes.
  • Collaborate with Quality Assurance for batch record validations.
  • Address product complaints and manage temperature deviations.
  • Ensure thorough documentation of investigational product supply activities.
  • Assist in the selection of drug supply vendors.
  • Facilitate the design and implementation of Interactive Response Technology (IRT) systems.

Qualifications:

  • Bachelor's degree in health or life sciences.
  • A minimum of 5 years of experience in the pharmaceutical sector, with at least 3 years in regulatory oversight.
  • Experience in product supply logistics is advantageous.
  • Familiarity with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and related regulations.
  • Proficient in MS Office and Electronic Data Capture (EDC) systems.
  • Exemplary leadership and communication abilities.

Compensation: $90,000 - $102,000 annually

About CPC Clinical Research:

We are a premier academic research organization specializing in the design and management of clinical trials across diverse therapeutic areas. With over three decades of expertise, we have successfully conducted numerous clinical studies focusing on cardiovascular health, wound healing, and diabetes management.

We provide a comprehensive benefits package, including 401(k) matching, paid holidays, vacation days, and sick leave, all within a collaborative work environment.

Equal Opportunity Employer:

CPC Clinical Research is committed to providing equal employment opportunities to all individuals, regardless of race, gender, color, religion, national origin, disability, or any other status protected by law. Qualified candidates will be selected based on job-related criteria.



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