Job Description

Clinical Supply Chain Specialist

This individual contributor is responsible for providing E2E logistics support for specific clinical compound finished kit shipments, as well as the management of logistics facing quality non-conformances.

• Logistics activities during clinical trial start-up (E2E) and transportation (finished kits):
• Advise on country importation requirements and coordinate country importation readiness finished kits shipments.
• Develop kits distribution and depot strategy with input from Trial Supply Manager, Clinical Supply Integrator, and Logistics Strategy.
• Provide shipping instructions to depot partners for finished kits shipments.
• Advise on adequate shipping solutions and perform shipment track-and-trace activities.
• Through cross-functional internal collaboration, manage and maintain the distribution budget for assigned clinical trials.
• Review, challenge, (when applicable) and approve invoices related to transportation activities.
• General activities in support of the global clinical distribution network:
• Manage multiple priorities and work independently, taking problem-solving initiative.
• Excel in a dynamic environment while identifying and implementing process improvements.
• Support other cross-functional improvement projects.
• Develop close working relationships with internal and external stakeholders, as well as cross-functional business partners.
• Logistics Non-Conformance Specialist (issue management):
• Perform logistical issue resolution activities pertaining to quality events/investigations for study compounds specific to finished kits.
• Communicate with internal stakeholders to compile investigational findings.
• Liaise with external suppliers to drive investigational efforts and CAPA implementation.
• Point-of-contact for CSC team regarding Logistical inquiries relating to non-conformances.
• Champion of compliance, with strong GxP insight

Focus and scope

• Responsible logistics set-up, issue management and specific transactional activities for clinical compounds within client R&D (large and small molecules and for all phases of clinical trials). Logistics SME and point-person for non-conformances.
• Travel: ~20%

Knowledge:

• Experience and understanding of the logistical aspects of clinical trial management, specifically supply chain logistics.
• Detail oriented, with the ability to adapt and incorporate new ways-of-working.
• Quality control, issue escalation, and CAPA support.
• Commitment to maintaining high standards of quality and compliance.
• Excellent communication and collaboration skills.
• Ability to work in a global, dynamic, and high-pressure environment.
• Cold chain and temperature management experience.
• Familiarity and understanding of GxP principles.
• Data collection and analytical skills with a commitment to data integrity.
• Commitment to continuous improvement initiatives with the ability to learn, grow, and adapt to unexpected changes.
• Experience managing a budget and forecast

Education/Experience:

• A university/bachelor’s degree (or equivalent experience) is required.
• Minimum of 2 years of logistics related experience, preferably in pharmaceutical distribution.
• A quality control or investigatory background preferred.
• Experience with supply chain, cold chain and temperature management preferred

Job Tags

Similar Jobs