Clinical Supplies Associate

Job Description:
We are seeking a detail-oriented and collaborative Clinical Supplies Associate, supporting temperature excursion (TE) management and broader clinical supply activities. This role is critical to ensuring the integrity and compliance of clinical trial materials across the supply chain.

Key Responsibilities:

• Monitor and assess temperature data for clinical trial shipments and on-site storage.

• Collaborate with Quality to evaluate product impact and determine appropriate disposition of materials.

• Track and report temperature excursion metrics.

• Document temperature excursions in accordance with SOPs and regulatory requirements.

• Update the Interactive Response Technology (IRT) system to support resupply shipments.

• Coordinate and support investigations related to excursions.

• Partner with clinical supply chain, quality assurance, and clinical sites to drive timely resolution.

• Assist with additional clinical supply activities, including product destruction, study close-out, and filing documents in the electronic Trial Master File (e-TMF).

Qualifications:
Background in pharmaceutical supply chain, cold chain management, or stability management required.
Understanding of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
Strong attention to detail and communication skills.
Experience working with IRT systems and documentation tools is a plus.
1-3 years minimum experience in related industry.

Bachelor's degree is required.