Senior Specialist, Clinical Supply Chain

Role Summary

Senior Specialist, Clinical Supply Chain

Responsibilities

• Primary monitor/representative for clinical site inventory management, temperature excursions, distribution, accountability, return and destruction of investigational medicinal product (IMP) for multiple Phase 3 clinical trials.
• Collaborate with cross-functional teams to ensure timely and accurate delivery of clinical supplies to study sites to support site activation and patient dose.
• Monitor global clinical supply inventory at the clinical site level for both IXRS/IRT and traditional studies via tracking milestone dates and adjusting drug distribution plans accordingly.
• Implement supply strategies to de-risk missed patient visits, maximize supply efficiency, and minimize waste.
• Identify and escalate supply chain risks and/or issues accordingly.
• Support IXRS/IRT development.
• Monitor and perform tasks within ERP and IXRS/IRT system(s).
• Support management of relationships with external vendors and supplies to ensure timely and cost-effective delivery of supplies.
• Participate in meetings and provide updates on project progress, milestones and potential risks.
• Maintain accurate and organized record of clinical supply chain activities and assist with data analysis as needed.
• Assist with Trial Master File (TMF) setup, maintenance, and closure, relating to IP Supplies.
• Prepare standard documents, such as purchase orders or shipping documentation.
• Identify areas for process improvement and make recommendations for increased efficiency and cost reduction.
• Adhere to all company policies and procedures including those related to safety, quality, and cGxP compliance.
• Continuously develop and expand knowledge of clinical supply chain processes.
• Assist with production planning and forecasting.

Qualifications

• Strong communication, problem solving, and time management skills.
• Ability to thrive in a fast-paced environment while remaining flexible, proactive, resourceful, efficient, and detail-oriented.
• Ability to complete tasks within agreed timelines and resources through managers‚Äô guidance.
• Ability to work well with a diverse team from various functions.
• Proficient in Microsoft Applications (Word, Excel, PowerPoint).
• Excellent written and verbal communication skills.
• Attention to detail and ability to prioritize tasks to meet critical deadlines.
• Strong commitment to compliance and ethical standards.

Education

• Associate or Bachelors degree in supply chain management or science-related field.

Experience

• 2+ years‚Äô experience in a Clinical Supply Chain role in a Biotechnology or Pharmaceutical environment, or 4+ years‚Äô relevant work experience in a similar field; bachelor‚Äôs degree required.
• 2+ years‚Äô experience working in a GxP regulated environment.
• Basic understanding of logistics and inventory management.
• Strong planning and organizational skills and a high level of flexibility while being detail-oriented.