Clinical Supply Support Specialist
📍 Location: On-site – Warren, NJ or Armonk, NY
About the Role
We are seeking a detail-oriented Clinical Supply Support Specialist to support clinical trial supply operations, ensuring efficient planning, execution, and documentation across studies. This role plays a critical part in maintaining supply continuity, regulatory compliance, and operational excellence within clinical development programs.
Key Responsibilities
Clinical Supply Planning & Execution
- Monitor and assess clinical supply inventory, including risks, stock levels, and trends
- Generate and maintain metrics and reporting data
- Process requisitions and support timely procurement of comparator drugs and ancillary supplies
- Track and manage comparator documentation updates
Clinical Supply Shipments
- Initiate manual (non-system generated) shipments
- Monitor and track comparator drug delivery schedules
- Coordinate depot transfers and site return shipments
- Manage and resolve temperature excursions
Documentation & Trial Master File (eTMF) Management
- Create and maintain Expected Document Lists (EDL)
- Update comparator Item Master Numbers (IMN)
- Maintain eTMF documentation in compliance with regulatory requirements
- Request QA/QP releases
- Perform pack-and-label kit and sequence reconciliation
- Support inspection readiness activities
- Manage IRT alerts and participate in User Acceptance Testing (UAT)
IP / Ancillary Supplies Compatibility Review
- Triage incoming requests and coordinate with functional teams for review
- Conduct research and liaise with manufacturers for compatibility information
- Enter and maintain data in systems (e.g., ASIST, spreadsheets, Teams)
Clinical Supply Systems & Operations
- Manage Clinical Supply Support (CSS) email inbox
- Administer IRT system access for study users
- Conduct periodic reviews (EDL, IRR, StiL) across studies
- Upload and manage TMF documentation in Veeva
- Support system UAT activities
Qualifications
Minimum Requirements:
- Bachelor’s degree in a relevant field (e.g., Life Sciences, Supply Chain, or related discipline)
- Internship or prior industry experience in a related field
Preferred Experience:
- 2+ years of experience in one or more of the following:
- Clinical Supplies
- QA / Regulatory
- Precision Medicine
- Supply Chain or Procurement
- Manufacturing
- Biopharma research or commercial operations
Key Skills
- Strong organizational and documentation skills
- Attention to detail and ability to manage multiple priorities
- Familiarity with clinical supply systems (IRT, Veeva, eTMF) preferred
- Effective communication and cross-functional collaboration
Why Join Us
This is an opportunity to contribute to critical clinical trial operations in a fast-paced, collaborative environment while gaining exposure across supply chain, regulatory, and clinical development functions.
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