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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