:
1. Finalize specifications with the client, including meetings at the client’s premises.
2. Set up and maintain study filing systems, ensuring accurate records are kept for all work undertaken.
3. Collaborate with the Project Manager to guarantee the timely fulfillment of all business tasks in alignment with customer and study specifications.
4. Coordinate and communicate relevant activities, both internal and external, to ensure all services and products are ready for the study's start.
5. Use project planning tools to communicate achievements, critical path activities, and responsibilities.
6. Provide timely reports and other information to customers when applicable.
7. Work with the Master Production Scheduler to optimize clinical supply production, balancing customer requirements with available capacity.
8. Support the creation of batch documentation and operational documents using internal systems, including billing package review.
9. Offer assistance to the Project Manager, involving financial and quote predictions.
10. Monitor project activities and establish customer-approved job specifications.
11. Collect information on study development, including label texts, coordination of packaging materials and tools, label translation, and producing batch documentation for operations.
12. Coordinate shipments through the logistics department and write distribution orders and GMP instructions promptly.
13.