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Proclinical is seeking a Clinical Supplies Project Coordinator to support the delivery of clinical supplies through effective project management. This role involves coordinating packaging and labeling processes, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams. The position requires a proactive approach to managing multiple projects in a dynamic environment.
Responsibilities:
1. Manage multiple clinical supply projects, ensuring timely delivery of finished supplies.
2. Collaborate with Drug Supply Managers to align packaging and labeling designs with study requirements.
3. Develop and track detailed schedules, milestones, and activities for assigned projects.
4. Coordinate the availability of deliverables such as drug products, components, randomization files, and label text.
5. Generate, review, and approve internal and external packaging and labeling production orders.
6. Create and release Bill of Materials and process orders in SAP, ensuring accuracy and compliance.
7. Execute SAP transactions, including goods receipt and consumption, and maintain accurate records.
8. Compile documentation to support the release of finished supplies for clinical use.
9. Liaise with Quality Assurance to secure the release of clinical supplies.
10. Manage outsourced projects, including vendor coordination, quotations, and purchase orders.
11. Ensure CGMP compliance and address deviations promptly.
12. Conduct root-cause analysis for quality investigations and complaints.
13. Identify opportunities for process improvement and participate in continuous improvement initiatives.
14. Author and review procedural documents as required.
Key Skills and Requirements:
15. Strong project management skills with the ability to manage multiple priorities.
16. Excellent oral and written communication skills.
17. Effective decision-making and organizational abilities.
18. Knowledge of regulatory and CGMP principles.
19. Familiarity with ERP/MRP systems and supply chain processes.
20. Ability to work collaboratively across functions and influence outcomes.
21. Eagerness to learn and continuously improve.
22. Bachelor's degree or equivalent in pharmacy, engineering, business, or life sciences.
23. Experience in the pharmaceutical industry or a related healthcare environment.