What are the responsibilities and job description for the Distribution Management Specialist (Pharma/GMP) position at Astrix?
Seeking a Distribution Management Specialist for our client - a global, research-driven pharmaceutical manufacturer. This role is responsible for independently planning, developing, and optimizing global Investigational Medicinal Product (IMP) distribution strategies for clinical studies across all phases of development. This role ensures compliant, efficient, and temperature-controlled distribution of clinical trial materials worldwide and serves as the primary logistics and distribution expert within cross-functional trial teams.
Type: Contract (2 years)
Location: Ridgefield, CT
Rate: $35 - $38/hr
Responsibilities
INDBH
Type: Contract (2 years)
Location: Ridgefield, CT
Rate: $35 - $38/hr
Responsibilities
- Independently develop, plan, and optimize global IMP distribution strategies for assigned clinical studies.
- Lead the setup and alignment of distribution concepts, including country- and site-specific requirements.
- Support the design and implementation of IRT (Interactive Response Technology) systems related to IMP distribution strategy, including depot structure, resupply logic, and shipment triggers.
- Manage, coordinate, and oversee external Distribution Partners (DPs) and Contract Manufacturing Organizations (CMOs) to ensure compliance with service level agreements.
- Serve as the primary distribution contact within the global CTSU Trial Team, ensuring alignment with Clinical Operations, Supply Chain, Quality, and other stakeholders.
- Independently analyze and assess temperature excursions related to IMP logistics and storage, determining appropriate actions and resolutions.
- Perform evaluation, documentation, and classification of deviations and complaints in applicable quality systems.
- Report, process, and close deviations and CAPAs in accordance with company Quality System requirements.
- Ensure full compliance with international regulatory, legal, customs, and GDP/GMP standards governing global clinical trial distribution.
- BS degree in a scientific field
- 3-5 years of experience in pharmaceutical logistics, import/export, or clinical supply chain management.
- Direct experience with Investigational Medicinal Products (IMPs) strongly preferred.
- Strong understanding of temperature-controlled logistics and cold chain management.
- Solid knowledge of GMP/GDP regulations and pharmaceutical quality systems.
- Familiarity with international customs and regulatory requirements for clinical trial materials.
INDBH
Salary : $35 - $38