Senior Clinical Supply Chain Specialist

Job Description

POSITION SUMMARY:
The Senior Clinical Supply Chain Specialist is responsible for the operational execution and coordination of investigational drug product (IP) distribution from a central pharmacy to clinical trial sites across multiple studies.

The role supports end-to-end supply activities including forecasting, demand planning, inventory management, shipment coordination, and issue resolution, ensuring uninterrupted, compliant supply to sites and patients throughout the trial lifecycle.

This position works cross functionally with Clinical Operations, IRT, and Data Management teams, Quality Assurance, depots, couriers, and sponsors to proactively assess supply needs, mitigate risk, and maintain inspection ready documentation in accordance with GCP/GDP requirements.

Responsibilities also include operational leadership for projects involving medication logistics, chain of custody, storage, dispensing, accountability, and data integrity of investigational drug products and ancillary supplies.

ACCOUNTABILITIES:
• Develop and maintain study level demand forecasts based on protocol design, enrollment projections, dosing schedules, and treatment duration.
• Translate enrollment updates, protocol amendments, and site activations into revised supply forecasts and resupply plans.
• Partner with Clinical Operations, IRT, and Data Management teams to align randomization rates, visit schedules, and supply triggers with operational reality.
• Monitor actual usage versus forecasted demand; identify trends, variances, and potential supply risks.
• Support scenario planning (e.g., accelerated enrollment, delayed site activation, cohort expansion) to inform mitigation strategies.
• Provide input into buffer stock and safety stock calculations to balance supply continuity with waste reduction.
• Coordinate day to day IP distribution from the central pharmacy to domestic clinical trial sites.
• Process site orders and resupply requests in accordance with approved forecasts and IRT parameters.
• Arrange courier shipments, select appropriate packaging configurations, and ensure on-time delivery.
• Support direct to site shipment models.
• Track IP inventory levels at the central pharmacy, depots, and clinical sites.
• Monitor expiry, batch usage, and site level consumption against forecasted demand.
• Identify and escalate risks related to low inventory, impending expiry, or over supply.
• Support reconciliation activities including returns, destruction, and study closeout inventory review.
• Manage ambient and cold chain shipments, including temperature monitoring device deployment and data review.
• Triage temperature excursions and logistics deviations in collaboration with QA and pharmacy leadership.
• Support investigations, documentation, and CAPA activities related to supply chain events.
• Maintain accurate, inspection ready documentation for forecasting assumptions, inventory movements, and distrib...