Aline Davis

Responsible for supporting Operations team in all Logistics needs as the primary of contact on Clinical Logistics, responding day to day operational activities in transporting sensitive shipments containing leukapheresis products, blood, human/animal tissues and samples (pk, biomarkers, vials of engineered human/animal T cells), Biopsy samples.

Responsible for place orders, tracking and shipping of laboratory kits and specimens to specialty labs and to labs for analysis. Also responsible for confirming addresses and contacts to receive the kits, monitoring of site supplies and restock requests, and coordination of parties to resolve lab queries related to sample management.

Managing all inbound/outbound activities related to scheduling, planning, and tracking of Clinical Trial shipments per Triumvira internal procedures, monitoring tariffs and customs regulations, reducing risk of delayed shipments.

Ensure that Chain of Custody and Identity is maintained through preparation and coordination of associated documentation or systems.

Working crossing function with internal and external team members to develop and implement logistics protocols, tracking systems and processes in support of ongoing Triumvira logistics needs.

Preparing all shipping documents as required for domestic and international shipments (Example: Commercial Invoice, Do Not X-Ray Letter, Letter of Authorization, Shipper Certification) with focus on transit of biologics (Category B, UN3373, others) based on ISO/FDA/DOT/IATA/HIPAA compliance regulations, moving goods between United States, Canada, European Countries, Asia and Latin America.

Communicating with logistics partners as needed, including vendors, site coordinators, CMO, ClinOps, Labs and customs brokers.

Evaluating carrier performance based on customer satisfaction, turnaround time, and other criteria to ensure customer satisfaction with services provided by carriers.

Analyzing data from shipping operations and creating reports, SLA's and Metrics to identify opportunities for improvement.

Developing processes that make the supply chain more efficient and organized.

Update Leukapheresis and Manufacturing schedules.

Supply Apheresis Centers and sites with materials for sample collection and shipments (Lab kits, C3 CRT Shippers, Requisition Form, Air Waybill, and more).

Primary contact for all clinical trial studies and responsible for communicating with all Country Study Managers (CSMs) for each study and study coordinators to provide daily updates on samples (shipments containing glass/plastic tubes with blood of human origin for clinical diagnosis examination) and lab material shipments (Empty glass tubes, Foil pouch, Gel pack, Sealable kit return bag for DNA and Laboratory analysis).

Researching, maintaining, and updating any import/ export requirements for all countries (Australia, Japan, Russia, Korea, Poland, Latin America, Canada, and more) that the company maintains business with to move samples from patients to be tested (Exempt Human Specimen and Biological Substance cat. B UN3373).

Ensures the packaging follows compliance with IATA regulations and DGR section 3.6.2.2.3.8.

Responsible for providing any required documentation to CSMs or sponsors and maintaining multiple spreadsheets containing all pertinent information for all shipments (Inbound/Outbound) and running/creating analysis reports regarding show trends and areas of improvement, including savings opportunities for a better result of the projects. Organizing and attending meetings/training with the internal/external teams to provide updates and align expectations with the team.

Responsible for all international shipments from the point of pickup through delivery, and it can be from/to different countries around the world and for creating import/export documents.

Ensures the lowest cost of transportation by analyzing company and customer needs, researching transportation methods, and auditing carrier costs and performances.

Check, analyze and provide all documents for the customs team based on the government rules for each country and if necessary, update and follow up with until clearance process is completed and making sure the shipment will be delivered to the destination.

Coordinate, monitor, and troubleshoot pickup requests with FedEx, DHL, Marken, Ocasa or any Courier for Customer or internal Sales to efficiently track inbound samples and outbound shipments including proactive troubleshooting and intervention providing feedback and solutions for improvement.

Update and Create reports of transit transactions according with the SLA, looking for efficiencies and utilize data to recommend system enhancements, process improvements, and potential solutions for company operations.

Working with customers to organize their homes, home offices, or small businesses.

Assignments ranged from individual closets to small businesses.

Cultivated new business with existing and new clients.

Provided checklists enabling customers to maintain appropriate supply levels.

Managed a team of 60 people with order processes, invoice processes, and order management logistics.

Managing of carrier with follow up performance, evaluation feedback, setting new goals and skills necessary to improve the grade position.

Support in the area of decisions and business strategy with customers and attending SOX audits.

Optimization of supply chain process to deliver better results of services agreed in contract.

Leadership of coordinators, analysts, and assistants’ logistics to guarantee all departments will deliver a positive result.

Responsible for hiring new employees with personal interview and group dynamics.

Definition the KPI’s and SLA’s to support the process management.

Principal contact with the customers to negotiate the forecast, demand, and diary priorities.

Identify the opportunities to improve the business and relationship satisfaction with Nokia.

Create process and metrics to collaborate understand the results and impacts on business

Follow up and meeting with warehouse (DHL-SP and Ceva-PR) to guarantee all solicitations will be processed and distributed on time to the final destination.

Supporting the team of SAP (SD version) system.

Certify the quality of service delivered to Nokia is satisfactory and according the period established in contract.

Cost reduction activities

Coordination of processing and billing process of telecommunications equipment and services through the SAP system.

Coordinator of Hub Item process team to certify all demand will be attended on time and with quality.

Managing people with the process delivery and personal performance (sense of responsibility, control time sheet and overtime).

Daily follow-up with the HUB (DHL-SP and CEVA-PR), to check if all orders will be complete and delivered on time.

Import Process: Order placement in Finland / China, Invoice issuance and Shipment Control (Green Light). Monitoring invoice receipt process to ensure GR and IR completed in the system to avoid fiscal issues. Issuance of incoming invoices and complementary invoice, control of import documents (Invoice, Packing List, DI, NFE, NFC).

KPI’s and SLA’s reports for internal controls