Clinical Supply Specialist

Job Description

Job Summary:

• The Clinical Supply Specialist is responsible for supporting clinical supply managers/leads in developing a robust clinical supply planning and execution function and capability for Client’s rapidly growing and dynamic clinical pipeline.
• Reporting to the Director, Global Clinical Supply and being part of the PDCS-CSM (Product Development and Clinical Supply – Clinical Supply Management) team, this position will be responsible for task-based activities within clinical supply chain, packaging/labeling operations, distribution, and systems support.

Duties and Responisbilities:

• Support clinical supply managers in ensuring clinical supply timelines for assigned clinical studies are met.
• Direct/oversee and schedule contract manufacturing packaging, labeling, and international. shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials.
• Support clinical supply managers to ensure all documentation required to set up packaging and labeling activities in time for study start is created.
• Support clinical supply managers with preparation for resupply packaging and labeling operations.
• Create shipment orders and liaise with external distribution vendors to ensure shipments are processed correctly and delivered on time; resolve any issues with shipments as needed.
• Ensure required import/export documentation is provided for shipments as needed.
• Maintain inventory management for assigned projects by interfacing with vendors to ensure that inventory systems are kept up-to-date, and that final product reconciliation is accurately completed.
• Be part of the Clinical Supply Management team to ensure operational performance is being achieved and improvement initiatives are being delivered, including ownership of smaller initiatives.
• Gather documentation for quality related activities as necessary (CAPAs, deviations, change controls).
• File documents in eTMF and conduct PQCs.

Required Qualifications:

• BS/BA degree in supply chain/logistics or pharmacy/drug development discipline or equivalent qualification.
• 1-3 years of experience in a (clinical) supply chain / logistics environment.
• Familiarity with pharmaceutical/clinical supply chain environment.
• Desire to increase knowledge within clinical supply chain area.
• Good planning, organizational and analytical skills.
• Ability to prioritize and meet deadlines.
• Strong diligence.
• Strong and clear communication skills.
• Proficiency with personal computers and Microsoft Office Products, including Word, Power Point, and Excel.

Preferred Qualifications:

• eTMF experience.
• Clinical supply management.