responsible for QA management of Phase I-IV clinical trials at investigator sites for compliance to study protocol, ICH-GCP, company’s SOPsInsured adherence of 25 clinical trials to ICH-GCP, GLP, Declaration of Helsinki, FDA control requirementsReviewed and negotiated clinical trial agreements and study budgets with investigator sites, prepared trial documents for submission to IRBs/IECs and Regulatory AuthoritiesProvided study related training for InvestigatorsAssisted in opening company branches Updated central database in International Management Package for Administration of Clinical Trials (IMPACT)Coordinated recall activities

responsible for operational and QA management of Phase I-IV clinical trials at investigator sites for compliance to study protocol, ICH-GCP, company’s SOPs and applicable regulationsEnsured site resource capabilities to meet project deadlinesSupervised 5 clinical trials for surgical drugs, 7 in oncology on-site (source data verification, drug accountability, data collection)Performed multiple site feasibility and investigator selections, screened over 1000 volunteersOrganized sponsor visits, prepared and submitted over 100 Monitoring Visit Reports within defined timelinesManaged and completed reporting of Adverse Events and Serious Adverse Events that occurred during trials on-site(2 events)

responsible for site monitoring, site management, registry management for Phase I-IV clinical trialsConducted Pre-study, Initiation, Routine, Close-Out visits for clinical studiesAssisted in site feasibility studies, communicated with sites to ensure adequate enrollment rateNegotiated clinical trials agreements and budgets with the investigator sitesControlled shipment and return of study materials

responsible for sale and distribution of cardiovascular, psychiatric, surgical, hematological drugs in hospitals and drugstores in Western region of UkraineIncreased sales over 100%(140K to 360 Euro) for Western region during December 2007- May 2008 period by raising doctor awareness about newer, more advanced productsImproved product marketing and distribution by using doctoral training to explain patient benefits of specific drugsPlanned special presentations and workshops for doctors

responsible for sale and distribution of Berlin Chemie drugs in hospitals and drugstores in Western region of UkraineImproved sales by 15% for Western region during December 2006-September 2007 period by building and maintaining new customer relationshipsUsed telephone marketing and personal visits to drugstores and hospitals to promote Berlin Chemie product distributionPrepared press kits, brochures, news releases, print and direct mail ads

responsible for QA management of Phase I-IV clinical trialsServed as Project Manager backup when required Assisted in opening new company branch in Chisineu(Moldova), purchased and commissioned new lab equipmentAssisted in training of Junior CRAsCollected and reviewed for compliance study documents from investigator sites, compiled trial master file

responsible for monitoring of Phase I-IV(pre-study, initiation, routine, and close-out) clinical trials• Helped senior personnel to prepare and submit 12 final study reports• Monitored studies daily with hospital personnel, prepared clinical trial reports and maintained database records• Purchased and setup equipment for study lab• Prepared documentation for Investigation Brochure and Informed Consent Forms for volunteers