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Summary

Registered Pharmacist in Uganda. Dedicated and efficient Trial pharmacist with more than seven years of expereience working in Clinical Trial settings. Experienced in Malaria, HIV, TB, Hypertension/Diabetes protocols. Strong understanding of regulatory affairs and ICH GCP compliance

Experiences

Current Experience

  • Senior Trial Pharmacist Kampala, Central Region, Uganda
    Since May 2009

    Part of the core clinical trial management team implementing trial management plan for all trials involving investiagtaional products

    More than seven years of experience working in clinical trial settings, both non-commercial (majority NIH funded) and commercially sponsored protocols, working as senior trial pharmacist for the ongoing Malaria, HIV, Hypertension/Diabetes trials.

    Strong understanding of regulatory affairs and ICH GCP compliance

    Great experience in;

    • Trial sites preparation, protocol trainings snd implementations, managing and control of investigational products;
    • Compiling regulatory documents for registration of new studies with the local regulatory authorities and submitting study annual renewals
    • Completing reports including incident reports, protocol violation reports, adverse drug reactions reports and processing import license for the shipments of investigational products
    • communicating and responding to study monitors and auditors, including clinical research organisations (CROs) supplying investigational products
    • managing investigational products
    • writing, review of standard operating procedures

Personality

Self Assessment :
Analytical thinkingAttention to detailFlexibilityOrganizationProblem solvingDependabilityCommunicative

Knowledge

Self Assessment :
Adverse Events (AE)Clinical monitoringClinical researchClinical Study DesignClinical study reportsClinical trial designClinical Trial SuppliesClinical trialsCRFCRF designDrug AccountabilityDrug Supply Management activitieseCRFEfficacy trialsGood Clinical Practice (GCP)Good Manufacturing Practice (GMP)ICH guidelinesInformed Consent ProcessInventory ManagementIVRSPhase IIPhase IIIPhase IVRegulatory affairsStudy approvalsStudy protocols

Skills and Expertise

Self Assessment :
Analytical skills Build and manage the Trial Master File (TMF) Create SOPs Interact with nurses Interact with physiciansAdverse event reportingArchive study documentsAssess site feasibilityAttend investigator meetingCapture data on source documentsCommunicate with investigatorComplete case report form (CRF)Ensure good clinical practice (GCP)Forecasting of drug productPrepare regulatory documentsRegulatory submissions

Education

  • Bachelor in Pharmacy from Makerere University College of Health Sciences in 2007

Training and Certification

  • Applied Clinical Research and Evidence-based medicine in 2016 Training
  • Good Clinical Practice course and Trial Management for Clinical Investigator/Coordinator in 2012 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    English
    Full Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Clinical Research Associate (CRA) Pharmacist
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Kampala, Central Region, Uganda

Others

Driving License
  • Yes