Jake Rashid's Email Addresses & Phone Numbers

📖 Summary

Clinical Research Intern @ Rockford Cardiovascular Associates From January 2013 to May 2013 (5 months) Rockford, ILProject Manager, Clinical Supplies @ Pfizer Lead the development and execution of investigational material supply strategies for early and late stage development programs on currently approved products within the Pfizer Essential Health (PEH) commercial business unit.Manage Clinical Supply Teams and a network of internal and external partners to ensure the PharmSci department meets stakeholder expectations and supports key Pfizer Clinical milestones. Greater Chicago AreaClinical Supplies Project Manager @ Experis Clinical trial management and oversight within the clinical supply chain.Project management consultant on contract with AbbVie and Baxter.Expertise in early phase requirements from cradle to grave - manufacturing, packaging & labeling, import/export, depot/site accountability, and destruction. IRT systems - UAT and utilization. Budgeting and purchasing (ancillary/Non-IMP & comparator drugs).Inventory systems / ERP systems.Overall conduit among clinical operations, analytical, manufacturing, and GMP QA groups. From August 2014 to July 2016 (2 years) Greater Chicago AreaClinical Project Coordinator @ Medpace • Manage and coordinate study activities supporting the needs of pharmaceutical sponsors and investigative sites to meet goals and timelines of a clinical trial. • Project Management principles relating to all significant regulatory, logistical, and subject issues at research sites to meet the demands of clinical operations. • Own internal CTMS & project management databases (e.g. Report generation, supply tracking, feasibility, milestones & timelines, enrollment projections, etc.). • Manage daily clinical site activity such as site initiation, product training, study enrollment, metrics tracking, reporting, clinical data flow, monitoring, and site closeout. • Oversee drug shipment logistics, and forecast timelines for site activation.• Provide strategic input preparing presentations, creating and maintaining project timelines in Microsoft Project.• Create and maintain project-specific reports & key deliverables throughout clinical trial: study specific documents, monitoring forms, physician clinic protocols, reference manuals, subject supplies, and more.• Meet all logistical, operational, and project management deliverables in coordination with the trial manager. From March 2014 to August 2014 (6 months) Cincinnati, Ohio AreaQuality Associate I @ Baxter International Inc. • Implemented and adhered to quality systems regulations• Determined FDA reportability• Managed adverse event workflow• Participated in process improvement projects From September 2013 to March 2014 (7 months) Round Lake, ILStrategic Project Management Intern @ Takeda Pharmaceuticals • Provide assistance to senior managers in the Pharmaceutical Development Division • Served as communication link between key stakeholders and Takeda• Participated in clinical trial update meetings for novel medicinal products• Trained in the laws and regulations associated with sponsor trials• Exposed to the global drug development process in various clinical phases• Optimized corporate timelines to more efficiently navigate through newly structured internal governance From May 2013 to August 2013 (4 months) Deerfield, ILResearch Assistant @ The University of Iowa • Engineered aspects of large-scale cell culture and R&D production processes• Managed and coordinated activities for laboratory assistants• Managed production of biopharmaceuticals, operation of downstream equipment and analytical instruments• Implemented and helped develop new procedures pertaining to the GMP SOP specified• Maintained laboratory inventory and purchased project specific or general materials• Managed equipment documentation reviews for FDA sanctioned auditing• Conducted research for contract clients From January 2010 to June 2011 (1 year 6 months) Center for Biocatalysis and BioprocessingClinical Supply Program Manager @ Takeda Pharmaceuticals Manage process and strategy for early compound/clinical studies in Global Clinical Trial Supply Chain within the Chicago Pharmaceutical Sciences department. Trial oversight and management of third-party IRT vendors and CMO's, to deliver investigational medicinal products globally. From June 2016 to May 2017 (1 year) Greater Chicago Area