Job Description

Clinical Supply Chain Specialist

This individual contributor is responsible for providing E2E logistics support for specific clinical compounds including API/DS, DP, and finished kit shipments.

Logistics activities during clinical trial start-up (E2E):

• Advise on country importation requirements and coordinate country importation readiness for API, DP, and finished kits shipments.
• Develop kits distribution and depot strategy with input from trial supply manager, coordinate depot readiness.
• Provide shipping instructions to distribution centers for API, DP and kits shipments.
• Advise on adequate shipping solutions.

Logistics transactional activities (finished kits):

• Perform shipment track and trace activities.
• Review, challenge, (when applicable) and approve invoices related to transportation activities.
• With cross-functional internal collaboration, manage and maintain the distribution budget for key trials.

Logistics issue management (E2E):

• Manage logistics issue resolution activities pertaining to quality event investigations regarding assigned compounds for finished kits.
• With guidance, support/coordinate issue resolution activities for API/DP
• General activities in support of the global clinical distribution network
• Own specific trial independent processes, such as distribution forecasts, maintaining the country distributions and logistics database.
• 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. PAGE 2/2 Focus and scope
• Responsible for E2E (API, DP and finished kits) 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).

Knowledge

• Experience and understanding of the logistical aspects of clinical trial management, specifically supply chain logistics.
• Excellent communication and collaboration skills.
• Ability to work in a global, dynamic, and high-pressure environment.
• Commitment to maintaining high standards of quality and compliance.
• Cold chain and temperature management experience.
• Understanding and familiarity with 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.
• Experience with issue escalation, management, and CAPA.
• Commitment to working in accordance to the client credo.

Education/Experience

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

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