Eva Allen Email and Phone Number

Supply clinical trial investigator sites with investigational product and ancillary supplies for US and Global trials. Forecast the amount of IP and ancillary supplies for the trial. Develop clinical labeling with Regulatory input. Develop distribution strategies with either internal capabilities or through external CTM vendor. Develop Pharmacy Manual. Develop user requirements for Interactive Web System that will manage site inventory and subject status. Ensure sites are adequately supplied with IP throughout the trial. Complete Drug accountability at study closeout. Project management throughout each phase of the trial with cross functional teams. At any time, manage supplies for four or more trials in various study phases.

In support of clinical and toxicological production processes- In preparation for the clinical or toxicological campaign, determine material needs based on planned number of lots. Maintain raw materials through external requisitions. For clinical production, generate CCR to implement new raw materials, including materials clearance, creating a new SAP number, purchase specification, CQAI, and testing procedures. Track receipt, inspection, and release of materials. Generate CCR to create Bill of Material in SAP. Execute SAP production Process Orders. Involved with shipping and receiving bulks to contract filling facility, both through physical management and within SAP. Create training matrices for clinical productionDepartment Designate Trainer - Train new employees and notify all employees of latest training requirements. Generate the reports that notify to managers weekly of employee training status. Schedule site mandated training in department monthly meetings. Complete biennial curricula review and revise training curricula. Liaison for department as it relates to questions about training from Performance Development.Department Archivist - Implement a records management system of archiving research notebooks and reports. Create system to organize internal documents that are not encompassed in site GMP systems. Work with vendors to convert all research notebooks to PDF. Once scanned, all research notebooks are archived in long-term off-site storage.

Maintain SAP for production.Manage the requisition, delivery, and organization of all production supplies.

Responsible for the day-to-day operation of the Technology laboratory. Support research scientists. Calibrate and troubleshoot analytical equipment according to SOPs: pH meters, conductivity meters, turbidimeter, spectrophotometer. Ensure GMP compliance. Chair weekly safety audit. Maintain inventory through BBP and SAP. Coordinate outside contracts: repairs (EMAC) and calibrations. Assist with projects, on an as needed basis.