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Location:
Mumbai, Maharashtra, India
Posted:
May 12, 2020

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Resume:

Ms.NamrataKuril Mobile:902-***-****

(Exp–*.*yrs.) E-mailaddress:adc6m6@r.postjobfree.com

Objective:

Tomaximizethepotentialsandutilizethem effectivelytoattainorganizationalgoalsand objectivesthroughpositiveattitude,flexibilityandanopenmindset.Toenhanceknowledgefor professionalgrowthinthefieldsofClinicalTrial&DataManagementandelevatetohigher achievementsincareerandprocureresponsibilitiesthataccountonthebasisofperformance anddiligentwork

AcademicCredentials:

DEGREE/DIPLOMA YEAROFPASSING BOARD/UNIVERSITY GRADE/PERCENTAGE Advancediploma

in

clinicalresearch

December2016 AceAcademyof

Clinical

Excellence

BGrade

BSc.(Zoology,

Chemistry,

Botany)

June2016 R.D.NationalCollege

(MUMBAI

UNIVERSITY)

A

Grade

HSC March2012 AlphaCollege.

(MaharashtraBoard)

45%

SSC March2010 St.CharlesHigh

School.

(MaharashtraBoard)

66%

ProfessionalSummary:

3.2yearsofOverallExperienceinClinicalDataManagement.ExpertinStudyStartup,Conduct andCloseoutactivitiesofClinicalDataManagement.ExperienceinleadingDataManagement ActivitiesforMultipleStudiesacrossdiverseTherapeuticAreas.WellversedwithVendor Management,QualityDataReviewandTraining.

HandsonexperienceofvariousClinicalToolslikeInForm6.0and6.1,Rave,J-Review,SQL,TIBCO

&MS-Office.

ProfessionalExperience:

CognizantTechnologySolutions,Mumbai(Feb2017–Aug2019) TataConsultancyService:(Sep2019-TillDate)

Position:JuniorDataManager

KeyResponsibilities:

•KnowledgeandunderstandingofthestudyrequireddocumentslikeProtocol,Edit CheckSpecifications,eCRFRequirements,AnnotatedeCRF,eCRFsCompletion Guidelines(eHelp),DataTransferAgreement(DTA),DataReviewPlan(DRP),Data ManagementPlan(DMP),ProjectPlan.

•WorkedextensivelyinPhaseI,II,IIIandIVElectronicCapturestudies.

•ExperienceindraftingValidationPlan(VP)ofDataValidationSpecification(DVS),Data StandardsDocument(DSD),Listings,Spotfire,PatientProfileandperformingUserAcceptance Testing(UAT)oftheTestCases,SubjectScenarios,Reports&Spotfiretotestthedatabase functionalityagainsttherequirementsmanually.

•ParticipatedinstudydocumentpreparationsuchasDataManagementPlan, ExternalDataSpecifications,EditCheckSpecification,eCRFRequirements&eCRF CompletionGuidelines.

•Preparationoftrainingmaterialforstartupandconduct.

•GoodunderstandingofTimeandEventsSchedule.

•PerformedDMconductactivitieslikeDiscrepancyManagement.

•Well-versedwiththeDataValidationandReconciliationActivitiesofElectronicCaseReports

(eCRF)throughSystemGenerated,Manual(ListingsofSAS,J-Review,DQCC)&External DataandSAE.

•ExecutionofDataListingProgramsandReviewPatientDataforConsistency, QualityandCompleteness.

•PerformedSiteTrendAnalysisonaregularbasisandpresentedittotherespectivestakeholders.

•ExperienceinperformingDataEntry&QualityControlofDataEntry.

•CreatedAd-HocreportsasperrequirementsinInForm.

•AttendedInvestigatorMeeting.

•Co-ordinatedwiththedifferentstakeholderssuchasSites,ClinicalOperationsTeam, Programmers,MedicalCoderstoensuretimelycompletionofdeliverables.

•Co-ordinatedwithExternalDataVendorsinrespecttotheReconciliationIssues.

•PerformedManualReviewofthestudyrelatedparametersonaregularbasisduringthe milestonessuchasCohortCleaningandDatabaseClose(DBC)period.

•WorkedasaMentorforDMteamindifferentstudies&performedPeerReviewforthe applicabledeliverablesmostlyinSet-upphasetoensureConsistency&Correctness.

•DeliveredProcessTrainingstothenewassociates.

•IdentifiedAreasofProcessImprovementsandcommunicateditwiththeTherapeuticLead.

•LeadDMactivitiesofMulti-CentricGlobalStudybyactingasthePointofContact(POC)for individualstudies.

•AttendedStudyCallsfollowedbypreparedMeetingMinutesandstudystatus

•EnsuredcompliancewiththeServiceLevelAgreement(SLA).

•Gavesuggestionorprocessimprovement.

•Identifieddataentrytrendsandgavesuggestionforimprovingit.

•ReviewedandfollowedprojecttimelinesandcoordinatedthedeliverableswiththeProjectLead. Skills(CoreCompetencies):

•SkilledinQualityReviewofDatasetsandinDiscrepancyManagement.

•ProficientinInFormandRAVEtool.

•CompetentinCoordinatingandManagingwithdifferentstakeholdersinthestudythrough MailsandWeeklyMeetings.

•GoodCommunicationinSpokenEnglishandCommandoverComprehension.

•AdeptinhandlingComputerAidedToolsandtheWebPlatform

•ExcellentTechnical,PresentationandInterpersonalSkills. PersonalDetails:

DateofBirth:21-JUNE-1994

Address:RoomNo1;DoodhwalaChawl,VakolaMasjid,Santacruz(East),Mumbai400055. LanguageKnown:Hindi,English,Marathi.

MaritalStatus:Unmarried.

Hobbies:Watchingmovie,Listeningmusic,Travelling,Meetingnewpeople(interacting),Cooking. Keystrength:Self-Confident,Self-Motivated,LeadershipTraits,TeamPlayer,HighlyEnergetic, Attentiontodetail,Quicklearner,FlexibilityandAdaptability,Decisionmaking, Coachingpeople,Responsible,GoalOriented,PrioritizingTask,Loyalty. Achievements:

•SuccessfullyhelpedinLockingCriticalStudiesbyprovidingfullStudyCloseOutsupport.

•ActedasaPointofContactinleadingDMteamforSet-upphase&Go-liveactivitiesand successfullybroughtastudyinProductionPhase.

•WorkedonStandardLibraryUATlikeCDASHonaProjectLevelandhelpedin incorporatingthesestandardformsinallthestudies.

•CertifiedasaTrainerbytheOrganization.

•AwardedbyClientastheStarPerformerofthemonthforacriticalStudy.

•AwardedbyManagementforasStaroftheMonth.

Declaration:

IherebydeclarethattheabovementionedinformationiscorrectuptomyknowledgeIandbear theresponsibilityforthecorrectnessoftheabovementionedparticulars.



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