Specialist in relational databases, now working for more than 9 years in a company providing EDC solutions for clinical trials.
AdaptabilityAnalytical thinkingAssertivenessAttention to detailCollaborationCommunicativeCreative thinkingCuriosityEfficiencyFlexibilityInterest in knowledgeProactivityProblem solvingService orientedSociabilityWillingness to compromise
21 CFR Part 11AuditingBusiness IntelligenceCDISCClinical Data ManagementClinical Study DesignClinical study reportsClinical trial designClinical Trial Management System (CTMS)Clinical trialsCoachingCommunication SkillsCRFCRF designCustomer ServiceData AnalysisData cleaningData entryData ManagementDatabase design and maintenanceDatabasesDesigning case report formseCRFEDCEnglishEvent ManagementFDAFunctional AnalysisGAMPGAMP5Good Clinical Practice (GCP)ICH guidelinesInformaticsInformation Management SystemsInformed Consent DocumentsInformed Consent ProcessISO 22000ISO 9001IVRSMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft ProjectMicrosoft WordOutlookPharmacovigilancePhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)Problem SolvingProgrammingPublic SpeakingQA complianceQuality AssuranceQuality Assurance (QA)Quality AuditingQuality Control (QC)Quality ManagementQuality Management System (QMS)Randomization and blindingRandomization SystemsSQLStandard Operating Procedure (SOP)Study protocolsSupply ChainTeam ManagementTestingTrainingTroubleshootingValidation
Skills and Expertise
Create SOPs Guide students Interact with nurses Interact with physiciansAct as the main line of communication between the sponsor and the investigatorAttend seminarsAttend investigator meetingAttend seminars, courses and meetings within and outside the companyCoachCoach and provide guidance to clinical staff.Coach clinical staffCoach staffCollect patient forms and questionnairesCommunicate effectively on different company levelsCommunicate with investigatorCommunicate with sponsorCommunicationUse content management systemsUpdate Clinical Trials Management System (CTMS) Understand protocolsTrain StaffTrain on site staffTrain off site staffSolve problemsReview study protocolsReview protocolsReview inclusion criteriaReview exclusion criteria
Master in Computer Sciences from FNUDP in 1989