Job Description
Job Summary:
- We are seeking an individual for the role of Specialist, Clinical Supply Chain – Operations. In this position, you will be responsible for the reliable and compliant execution of clinical supply across multiple protocols, ensuring materials are delivered to sites and patients on time.
- You will focus on day-to-day operational execution activities for assigned protocols, working closely with cross-functional teams including Clinical Operations, Quality Assurance, Regulatory Affairs, and external vendors.
- You will contribute to ensuring uninterrupted supply, managing execution activities, and maintaining visibility to supply status in a dynamic clinical trial environment.
Duties & Responsibilities:
- Lead end-to-end execution of clinical supply activities including packaging, labeling, distribution, inventory management, and study closeout.
- Execute supply activities aligned to protocol timelines (e.g., site readiness, patient supply, resupply management).
- Maintain visibility to inventory levels and supply availability across assigned studies.
- Partner with Clinical Operations, QA, and vendors to execute clinical supply plans.
- Support management of IRT systems including system use for supply tracking and resupply execution.
- Identify and escalate execution risks such as delays, supply constraints, or deviations.
- Support investigation and documentation of temperature excursions and supply deviations.
- Ensure execution activities are compliant, appropriately documented, and inspection-ready.
- Contribute to process improvements and support adoption of tools and ways of working.
- Maintain accurate documentation including supply plans, trackers, and required clinical supply.
Required Qualifications:
- BS degree in Life Sciences or Supply Chain Management.
- Experience: 3+ years of relevant experience.
- Confident Understanding of end to end clinical supply chain activity.
- Experience with IRT systems.
- Experience with CMOs.
- Strong understanding of GxP.
- Proficient knowledge of MS Office (Excel, PowerPoint, Visio, Project, etc.).
- Demonstrated flexibility to adapt to external environment influences through identifying new strategies and tactics
Strong attention to detail. - Excellent communication and collaboration skills across multiple stakeholders.
- Ability to multi-task and manage multiple priorities.