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 distribution activities.
• Ensure all activities comply with GCP, GDP, GMP, protocol requirements, and internal SOPs.
• Support sponsor audits, internal audits, and regulatory inspections.
• Serve as a primary operational contact for clinical sites regarding supply availability and shipment status.
• Collaborate with depots, packaging vendors, and couriers to resolve supply issues and improve performance.
• Communicate forecast changes and supply risks clearly to study teams and management.
• Identify opportunities to improve forecasting accuracy, resupply efficiency, and inventory utilization.
• Contribute to SOP development and process enhancements related to demand planning and supply execution.
• Participate in metrics development and reporting (e.g., forecast accuracy, stock out risk, waste reduction).

REQUIRED QUALIFICATIONS:
Knowledge of:
• Demonstrated knowledge of regulatory, operational, logistical, and data-driven aspects of investigational product (IP) management.
• Demonstrated expertise in clinical research and advanced project management skills.
• Data integrity, documentation standards, and audit readiness in regulated environments.

Ability to:
• Communicate effectively with diverse stakeholders, including clinicians, site investigators, pharmacists, distributors, vendors and senior leadership.
• Analyze complex operational challenges and implement practical, compliant solutions.
• Exercise independent judgement, be timely in meeting responsibilities.
• Demonstrate decision-making skills and project management experience.
• Exhibit a high degree of organizational skill, the ability to multi-task, and demonstrate a self-directed work effort.
• Exercise commitment to customer service with excellent, respectful communication skills and professional demeanor.
• Utilize spreadsheets, databases, and reporting tools to manage and interpret operational data.
• Must exemplify our NMDP Standards.

Education and/or Experience:
• Bachelor's degree in supply chain, life sciences, logistics, pharmacy operations, or related field
• Bachelor's degree and six years' experience or Master's degree and four years' experience in clinical trial supply chain, central pharmacy operations, or IP logistics Four years full-time NMDP employment in scientific-based position may be substituted for the six/four years work experience.
• Experience supporting forecasting, inventory planning, or resupply decision making in a regulated environment.
• Working knowledge of GCP, GDP, and clinical trial documentation requirements.

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
• Relevant Master's degree or PharmD preferred
• CRO experience supporting multiple sponsors and protocols simultaneously.
• Familiarity with IRT/RTSM systems and supply parameter configuration.
• Experience with high complexity therapeutic areas (e.g., oncology).
• Strong Excel or supply tracking system proficiency.Responsibilities

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 distribution activities.
• Ensure all activities comply with GCP, GDP, GMP, protocol requirements, and internal SOPs.
• Support sponsor audits, internal audits, and regulatory inspections.
• Serve as a primary operational contact for clinical sites regarding supply availability and shipment status.
• Collaborate with depots, packaging vendors, and couriers to resolve supply issues and improve performance.
• Communicate forecast changes and supply risks clearly to study teams and management.
• Identify opportunities to improve forecasting accuracy, resupply efficiency, and inventory utilization.
• Contribute to SOP development and process enhancements related to demand planning and supply execution.
• Participate in metrics development and reporting (e.g., forecast accuracy, stock out risk, waste reduction).

REQUIRED QUALIFICATIONS:
Knowledge of:
• Demonstrated knowledge of regulatory, operational, logistical, and data-driven aspects of investigational product (IP) management.
• Demonstrated expertise in clinical research and advanced project management skills.
• Data integrity, documentation standards, and audit readiness in regulated environments.

Ability to:
• Communicate effectively with diverse stakeholders, including clinicians, site investigators, pharmacists, distributors, vendors and senior leadership.
• Analyze complex operational challenges and implement practical, compliant solutions.
• Exercise independent judgement, be timely in meeting responsibilities.
• Demonstrate decision-making skills and project management experience.
• Exhibit a high degree of organizational skill, the ability to multi-task, and demonstrate a self-directed work effort.
• Exercise commitment to customer service with excellent, respectful communication skills and professional demeanor.
• Utilize spreadsheets, databases, and reporting tools to manage and interpret operational data.
• Must exemplify our NMDP Standards.

Education and/or Experience:
• Bachelor's degree in supply chain, life sciences, logistics, pharmacy operations, or related field
• Bachelor's degree and six years' experience or Master's degree and four years' experience in clinical trial supply chain, central pharmacy operations, or IP logistics Four years full-time NMDP employment in scientific-based position may be substituted for the six/four years work experience.
• Experience supporting forecasting, inventory planning, or resupply decision making in a regulated environment.
• Working knowledge of GCP, GDP, and clinical trial documentation requirements.

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
• Relevant Master's degree or PharmD preferred
• CRO experience supporting multiple sponsors and protocols simultaneously.
• Familiarity with IRT/RTSM systems and supply parameter configuration.
• Experience with high complexity therapeutic areas (e.g., oncology).
• Strong Excel or supply tracking system proficiency.