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Summary

I am a trained and Registered Pharmacist with the Pharmacy and Poison's Board of Kenya.

I have over 15 years of Experience in Clinical Trials, from being a Site Research Pharmacist handling IMP and all that concerns import, storage, dispensing, accountability to its eventual destruction or Return to the Sponsor.

Since 2006, I have been a CRA and rose through the ranks to become the Regional Manager covering the East African Market.

I have experience working in the following Countries; Kenya, Tanzania, Uganda, Rwanda, Malawi, Zambia, South Africa, Mozambique, Democratic Republic of Congo, Nigeria, Senegal, Zambia, Ivory Coast, Ehtiopia and Gabon.

My Key Strengths are Strong Operations Knowledge Base, Being able to work in a Team environment and Mentoring young professionals in and into Clinical Research.

 

 

Experiences

Current Experience

  • Senior CRA and Regional Manager Nairobi, Kenya
    Since October 2014

    Handle all duties of a CRA, SCRA as well as Business development and Opportunities.

Past Experience

  • Senior Clinical Research Associate (SCRA) Nairobi, Kenya
    February 2010 --- September 2014

    All Duties of a CRA and SCRA

  • Clinical Research Associate (CRA) Nairobi, Kenya
    October 2007 --- January 2010

    All Duties of a CRA

  • Clinical Research Associate (CRA) Nairobi, Kenya
    June 2006 --- September 2007

    Handles all Duties of CRA. 

    From Site Identification, Selection, Initiation, Monitoring, Audit and Close Out.

  • Chief Pharmacist Kisumu, Kenya
    February 2002 --- February 2006

    Chief Pharmacist.

Personality

Self Assessment :
OrganizationPerspectiveAttention to detailCollaborationDependabilityResult OrientedKindness

Knowledge

Self Assessment :
Phase I R&D21 CFR Part 11Actions and modes of action of drugs in the human speciesActions and modes of action of human physiologyAdverse Events (AE)Business DevelopmentBusiness IntelligenceBusiness Process ImprovementClinical monitoringClinical operationsClinical researchClinical SuppliesClinical trial audits and inspectionsCRFCRF designCROCTMSCurrent Good Manufacturing Practice (CGMP)Customer ServiceData cleaningData entryData ManagementDrug Supply Management activitieseCRFEDCElectrocardiogram (ECG)EnglishGood Clinical Practice (GCP)Good Laboratory Practice (GLP)Good Manufacturing Practice (GMP)HospitalsInfectious diseasesInformed Consent DocumentsInformed Consent ProcessMultilingualNew Drug Application (NDA)Patient Follow UpPatient recruitmentPatient Screening and RecruitmentPharmaceutical IndustryPharmaceutical ManufacturingPharmaceutical ResearchPharmaceuticalsPharmaceuticsPharmacistsPharmacyPhase IPhase IIIPhase IIPhase IVPhases of clinical development (phase I to IV)Quality Assurance (QA)Quality Control (QC)Quality AuditingQuality ManagementQuality Management System (QMS)Regulatory ComplianceRegulatory RequirementsSerious Adverse Event (SAE)TranslationVaccines

Skills and Expertise

Self Assessment :
Create SOPs Build and manage the Trial Master File (TMF) Guide studentsAct as the main line of communication between the sponsor and the investigatorAdminister supply requestAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAdverse event reportingApprove consent documentsApprove drug supply Approve Label Master SheetApprove monitoring reportsApprove patient informationApprove queriesApprove suitability of patient information and consent documentsArchive documentationArchive study documentsArchive trial documentation and correspondence.Assist with site trainingAttend investigator meetingAttend at steering committee meetingsAttend seminarsCommunicate with investigatorCommunicate with sponsorCommunicationCompile informationComplete case report form (CRF)Complete study proceduresConduct close-out visitsConduct site initiationConduct studiesConduct research at universitiesConduct the trialConfirm protocol complianceCoordinate ethics committeeCoordinate projectsEnsure good clinical practice (GCP)Follow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesGuide studentsIdentify investigatorsIdentify and provide training to trial team and associated staffImplement Quality Management System (QMS)Informed consent processInitiate clinical trials Interact with CROsInteract with KOLInteract with nursesInteract with pharmacistsInteract with physiciansInteract with regulatory stakeholdersInventory ManagementLead teamsLiaise with research teamLiaise with doctors and other professionals throughout the studyManage Clinical Trial Management System (CTMS) Manage clinical suppliesManage regulatory activitiesManage subject consent formmanaging a small teamMonitor dataMonitoring enrolmentMonitoring subject compliancePatient recruitmentResolves queriesRetrieve study documentsReview clinical study reportsReview exclusion criteriaReview inclusion criteriaReview informed consent processReview monitoring reportsReview study protocolsSite managementSolve problemsStudy execution planSupervise clinical monitorsSupervise trial suppliesTrain on site staffWork cross-functionally

Education

  • Post Graduate Certificate in Clinical Research Administration from Liverpool University in 2014
  • Degree in Pharmacy from Karnatak University in 1998

Training and Certification

  • CCRA in 2009 Certification
  • Registered Pharmacist (Dr.) in 2001 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency

Area / Region

Nairobi, Kenya

Others

Driving License
  • Yes