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Summary

Dear Reader,

I have nearly 13 years’ experience within the global Data Management industry, with experience across a huge range cultures, different people and countries that I worked with during the years.

Wish to (permanently) relocate to Europe, since I consider Europe the geographical heartland of the latest R&D innovation and at the forefront of the breakthroughs in Data Management.  In line with The European Union Directive 2009/50/EC of 25 May 2009 signed in Brussels, Belgium (on the conditions of entry and residence of third-country nationals for the purposes of highly qualified employment), I obtained EU Blue Card Status from The European Commission, for which a Candidate ID (and 100% EU Eligibility) has already been issued, together with a viewable profile, available at https://www.apply.eu/share/2be10

Should you require any additional information regarding the EU Blue Card Directive, please have a look at http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32009L0050&from=EN

Please note: No sponsorship, work permit, residency permit etc. required under the EU Blue Card Directive. If you have any questions, I shall be more than happy to explain.

Should you perhaps have any questions, or require any additional information/documentation, please do not hesitate in contacting me.

 

G.J. Ellis

Phone: +27 60 975 1234

Direct E-mail: deon.ellis@me.com

Experiences

Current Experience

  • Operational Effectiveness Specialist 2 Bloemfontein, Free State, South Africa
    Since December 2015

    • Participate in client engagements and directly contribute to achievement of project deliverables including research analysis plans, progress reports, technical reports, presentations, abstracts, surveys, discussion guides or other documents.
    • Serve as team lead on engagements and oversee risk assessments, compliance audits and other engagements.
    • Provide consultation regarding client issues and make recommendation on appropriate solutions.
    • Deliver expert presentation on topics of interest to potential clients.
    • Present research findings to industry clients and at professional conferences.
    • Generate Income Potential.
    • Contribute to business development activities. Evaluate current assignments and work to assist with the development expanded opportunities.
    • Provide technical expertise.
    • Support global focused Operational Effectiveness Services teams through active participation providing advanced technical expertise supporting project planning, change/data/process management and compilation of high quality deliverable generation for service area initiatives.
    • Assist project and senior project leads with initial data and process analysis including but not limited to: conducting research/interviews, identifying appropriate data resources, creating process maps, supporting project and change management plans, gathering data, preparing project outputs for assigned projects/analyses.
    • Assume responsibility and apply complex techniques for assigned sub-projects or specific project components including but not limited to: data modelling, analysis, innovative approaches, and Lean Six Sigma application, brainstorming, investigating theories, and project planning.
    • Attend and provide background and supporting documentation/findings regarding data collection and analysis at various meetings and planning sessions.
    • Participate in discussions with operations, Operational Effectiveness Services and management teams as required in carrying out special projects impacting the organization and productivity/process improvement initiatives.
    • Work with Operational Effectiveness Services project leads to create, collect and analyse data around metrics, change/process/data management, scorecards, and project plans supporting various Operational Effectiveness Services projects.
    • Project coordination and control tasks include: task and work flow planning, research approach planning, data source identification, clarification of project specification adjustments, identifying and collecting relevant and key records and documentation, general project related activities.
    • Support the preparation of project related reporting, development of user ready charts, and presentation materials for Operational Effectiveness Services management and ultimately Executive Management.
    • Provide on-the-job training to new team members as needed.
    • Performing Health Technology Assessments for current and potential customers, making use of various HTA-related agencies (for mainly Germany, Austria and Switzerland), i.e. EUnetHTA, European Medicines Agency (EMA), European Public Assessment Reports (EPAR), Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), Der Gemeinsame Bundesausschuss (G-BA), Eidgenösische Arzneimittelkommission (EAK), Schweizerisches Heilmittelinstitut, Gesunheit Österreich GmbH and Ludwig Boltzmann Institute for Health Technology Assessment.
    • Assessments performed for Germany, performed in line with Gesetz zur Neuordnung des Arzneimittelmarktes in der gesetzlichen Krankenversicherung (Arzneimittelmarktneuordnungsgesetz – AMNOG).

Past Experience

  • Data Manager Bloemfontein, Free State, South Africa
    April 2010 --- November 2015

    • Serve as Lead Data Manager from time to time, representing the CDM (Clinical Data Management) Team on the Corporate Project Team.
    • Perform/initiate comprehensive data management tasks pertaining to the Data Management Plan and cycles processes.
    • Perform/initiate comprehensive quality control procedures.
    • Provide data management expertise and data coordination process improvement to the Clinical Data Management Department.
    • Mentor other team members in training and developing data management expertise.
    • Independently bring project solutions to the Clinical Data Management team and the Clinical Data Management department.
    • Assist in developing and implementing new technology.
    • Serve in a leadership or managerial role to a specific DM (Data Management) Task or Team or a whole set of tasks.
    • Manage delivery of projects through full data management study life-cycle.
    • Manage project timelines (in cooperation with the program lead) and Sub-Saharan Africa Manager).
    • Management of quality (in cooperation with the program lead) and Sub-Saharan Africa Manager).
    • Determining resource needs (in cooperation with the program lead) and Sub-Saharan Africa Manager).
    • Identify Out of Scope Work.
    • Providing training and supervision to team members assigned as resources on projects.
    • Provide leadership to DM team.
    • Interact with CDM (Clinical Data Management) team members to negotiate timelines and responsibilities.
    • Develop and maintain good communications and working relationships with CDM (Clinical Data Management) team.
    • Meet objectives as assigned.
    • Understand and comply with core operating procedures and working instructions.
    • Provide input for negotiations with customer.
    • Manage project timelines and quality issues, determine resource needs, and identify and justify work out-of-scope.
    • Manage DM (Data Management) customer relationship for DM project team including active participation in DM customer negotiation on timeline, budgetary and other issues.
    • Solves issues through using the global issue escalation/communication plan.
    • Consult with Standards Group for process issues; communicate ideas for process improvement.
    • Perform comprehensive data management tasks including data review, writing and resolving data clarifications.
    • Training received in FDA (Food and Drug Administration) and EU Regulations with regards to Clinical Trials.
    • Trials and research performed in accordance with FDA Regulations, European Clinical Trials Directive 2001/20/EC (Luxembourg), European Regulation (EU) 536/2014 (Strasbourg), ERES Part 11 Compliancy and according to ICH GCP (International Conference on Harmonization of Technical Requirements for Good Clinical Practice) Guidelines.

  • Data Operations Coordinator Bloemfontein, Free State, South Africa
    March 2009 --- March 2010

    • Serve as Lead Data Manager from time to time, representing the CDM (Clinical Data Management) Team on the Corporate Project Team.
    • Perform/initiate comprehensive data management tasks pertaining to the Data Management Plan and cycles processes.
    • Perform/initiate comprehensive quality control procedures.
    • Provide data management expertise and data coordination process improvement to the Clinical Data Management Department.
    • Mentor other team members in training and developing data management expertise.
    • Independently bring project solutions to the Clinical Data Management team and the Clinical Data Management department.
    • Assist in developing and implementing new technology.
    • Serve in a leadership or managerial role to a specific DM (Data Management) Task or Team or a whole set of tasks.
    • Manage delivery of projects through full data management study life-cycle.
    • Manage project timelines (in cooperation with the program lead) and Sub-Saharan Africa Manager).
    • Management of quality (in cooperation with the program lead) and Sub-Saharan Africa Manager).
    • Determining resource needs (in cooperation with the program lead) and Sub-Saharan Africa Manager).
    • Identify Out of Scope Work.
    • Providing training and supervision to team members assigned as resources on projects.
    • Provide leadership to DM team.
    • Interact with CDM (Clinical Data Management) team members to negotiate timelines and responsibilities.
    • Develop and maintain good communications and working relationships with CDM (Clinical Data Management) team.
    • Meet objectives as assigned.
    • Understand and comply with core operating procedures and working instructions.
    • Provide input for negotiations with customer.
    • Manage project timelines and quality issues, determine resource needs, and identify and justify work out-of-scope.
    • Manage DM (Data Management) customer relationship for DM project team including active participation in DM customer negotiation on timeline, budgetary and other issues.
    • Solves issues through using the global issue escalation/communication plan.
    • Consult with Standards Group for process issues; communicate ideas for process improvement.
    • Perform comprehensive data management tasks including data review, writing and resolving data clarifications.
    • Training received in FDA (Food and Drug Administration) and EU Regulations with regards to Clinical Trials.
    • Trials and research performed in accordance with FDA Regulations, European Clinical Trials Directive 2001/20/EC (Luxembourg), European Regulation (EU) 536/2014 (Strasbourg), ERES Part 11 Compliancy and according to ICH GCP (International Conference on Harmonization of Technical Requirements for Good Clinical Practice) Guidelines.

  • Senior Clinical Data Coordinator Bloemfontein, Free State, South Africa
    March 2007 --- February 2009

    • Serve as Lead Data Manager from time to time, representing the CDM (Clinical Data Management) Team on the Corporate Project Team.
    • Perform/initiate comprehensive data management tasks pertaining to the Data Management Plan and cycles processes.
    • Perform/initiate comprehensive quality control procedures.
    • Provide data management expertise and data coordination process improvement to the Clinical Data Management Department.
    • Mentor other team members in training and developing data management expertise.
    • Independently bring project solutions to the Clinical Data Management team and the Clinical Data Management department.
    • Assist in developing and implementing new technology.
    • Serve in a leadership or managerial role to a specific DM (Data Management) Task or Team or a whole set of tasks.
    • Manage delivery of projects through full data management study life-cycle.
    • Manage project timelines (in cooperation with the program lead) and Sub-Saharan Africa Manager).
    • Management of quality (in cooperation with the program lead) and Sub-Saharan Africa Manager).
    • Determining resource needs (in cooperation with the program lead) and Sub-Saharan Africa Manager).
    • Identify Out of Scope Work.
    • Providing training and supervision to team members assigned as resources on projects.
    • Provide leadership to DM team.
    • Interact with CDM (Clinical Data Management) team members to negotiate timelines and responsibilities.
    • Develop and maintain good communications and working relationships with CDM (Clinical Data Management) team.
    • Meet objectives as assigned.
    • Understand and comply with core operating procedures and working instructions.
    • Provide input for negotiations with customer.
    • Manage project timelines and quality issues, determine resource needs, and identify and justify work out-of-scope.
    • Manage DM (Data Management) customer relationship for DM project team including active participation in DM customer negotiation on timeline, budgetary and other issues.
    • Solves issues through using the global issue escalation/communication plan.
    • Consult with Standards Group for process issues; communicate ideas for process improvement.
    • Perform comprehensive data management tasks including data review, writing and resolving data clarifications.
    • Training received in FDA (Food and Drug Administration) and EU Regulations with regards to Clinical Trials.
    • Trials and research performed in accordance with FDA Regulations, European Clinical Trials Directive 2001/20/EC (Luxembourg), European Regulation (EU) 536/2014 (Strasbourg), ERES Part 11 Compliancy and according to ICH GCP (International Conference on Harmonization of Technical Requirements for Good Clinical Practice) Guidelines.

  • Clinical Data Coordinator Bloemfontein, Free State, South Africa
    March 2005 --- February 2007

    • Serve as Lead Data Manager from time to time, representing the CDM (Clinical Data Management) Team on the Corporate Project Team.
    • Perform/initiate comprehensive data management tasks pertaining to the Data Management Plan and cycles processes.
    • Perform/initiate comprehensive quality control procedures.
    • Provide data management expertise and data coordination process improvement to the Clinical Data Management Department.
    • Mentor other team members in training and developing data management expertise.
    • Independently bring project solutions to the Clinical Data Management team and the Clinical Data Management department.
    • Assist in developing and implementing new technology.
    • Serve in a leadership or managerial role to a specific DM (Data Management) Task or Team or a whole set of tasks.
    • Manage delivery of projects through full data management study life-cycle.
    • Manage project timelines (in cooperation with the program lead) and Sub-Saharan Africa Manager).
    • Management of quality (in cooperation with the program lead) and Sub-Saharan Africa Manager).
    • Determining resource needs (in cooperation with the program lead) and Sub-Saharan Africa Manager).
    • Identify Out of Scope Work.
    • Providing training and supervision to team members assigned as resources on projects.
    • Provide leadership to DM team.
    • Interact with CDM (Clinical Data Management) team members to negotiate timelines and responsibilities.
    • Develop and maintain good communications and working relationships with CDM (Clinical Data Management) team.
    • Meet objectives as assigned.
    • Understand and comply with core operating procedures and working instructions.
    • Provide input for negotiations with customer.
    • Manage project timelines and quality issues, determine resource needs, and identify and justify work out-of-scope.
    • Manage DM (Data Management) customer relationship for DM project team including active participation in DM customer negotiation on timeline, budgetary and other issues.
    • Solves issues through using the global issue escalation/communication plan.
    • Consult with Standards Group for process issues; communicate ideas for process improvement.
    • Perform comprehensive data management tasks including data review, writing and resolving data clarifications.
    • Training received in FDA (Food and Drug Administration) and EU Regulations with regards to Clinical Trials.
    • Trials and research performed in accordance with FDA Regulations, European Clinical Trials Directive 2001/20/EC (Luxembourg), European Regulation (EU) 536/2014 (Strasbourg), ERES Part 11 Compliancy and according to ICH GCP (International Conference on Harmonization of Technical Requirements for Good Clinical Practice) Guidelines.

  • Clinical Nephrophysiologist Bloemfontein, Free State, South Africa
    September 2002 --- February 2005

    • Dialysis of Renal Impaired patients
    • Administration of medication as per Medical Specialist Instruction / Prescription
    • Reverse Osmosis System Maintenance and Water Quality Control
    • Wound care and treatment
    • Dialysis machine, infrastructure and systems maintenance
    • Training of other staff members in the correct and successful use of dialysis machines and Reverse Osmosis Water System Usage
    • Administration of patient documentation
    • Financial Budget Management of Renal Unit, Renal Unit Administrative Management
    • Tracing budget consumption of unit and trials conducted in that unit.
    • Established relations with representatives of pharmaceutical companies
    • Stock Orders and stock control
    • Financial Billing (for services provided)
    • Patient and Family Counselling
    • Patient Screening and recruitment
    • Completion of Case Report Forms
    • Administration of clinical trial and trial documentation according to company policies and requirements and adhering to ICH GCP (International Conference on Harmonization of Technical Requirements for Good Clinical Practice) Standards during the start-up, conduct and close-out of clinical trials.
    • Review and evaluations of patient documentation/integrity of data during trial conduct
    • Coordination of staff
    • Maintenance of emergency procedures and emergency procedure plans as required by Hospital policy
    • Development and maintenance of risk management plans and contingency plans
    • Training of junior staff members and student Clinical Technologists (Renal Medical Technicians) busy with internship
    • Tracking of Patient Report Forms
    • Compiling of clinical reports to be forwarded to medical specialists based on clinical evidence found during treatment

Personality

Self Assessment :
AdaptabilityAnalytical thinkingApproachabilityAttention to detailAuthenticityCollaborationCommunicativeCompetitivenessCoordinationCreative thinkingCuriosityDependabilityDiligenceEfficiencyFlexibilityIndividualityIndependenceInnovative thinkingKindnessOptimismOrganizationPerspectiveProactivityProblem solvingResponsibilityResult OrientedSelf-confidenceSelf-disciplineService orientedStrategic thinkingWillingness to compromise

Knowledge

Self Assessment :
Diabetes Negotiation Phase I R&D Scientific writing21 CFR Part 11Adverse Events (AE)AnalysisApplicationsAseptic TechniquesBioinformaticsBiologyBiomedical SciencesBiopharmaceuticalsBiotechnologieBiotechnologyBudget ProcessBusiness IntelligenceBusiness ProcessBusiness ProcessesCancerCardiologyCardiovascular diseasesCDISCClinical Data ManagementClinical Data Management (CDM)Clinical operationsClinical pharmacologyClinical researchClinical Study DesignClinical study reportsClinical trial audits and inspectionsClinical trial designClinical trial managementClinical Trial Management System (CTMS)Clinical trialsCoachingComplianceCompliance with regulationsCRFCRF designCROCross-functional team leadershipCTMSData AnalysisData cleaningData ManagementDesigning case report formsDeveloping Clinical Trial ProtocolsDiabeteseCRFEDCEfficacy trialsElectrocardiogram (ECG)Electronic Data Capture (EDC) EnglishFDAGermanGood Clinical Practice (GCP)Human AnatomyInformed Consent DocumentsInformed Consent ProcessIVRSKnowledge of the drug development processMicrosoft OfficeMonitoring Study ProgressMultilingualNephrologyOracle ClinicalPhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)PhysiologyPresentation SkillsSerious Adverse Event (SAE)Standard Operating Procedure (SOP)TeamworkValidationWriting Study Procedures and SOPs

Skills and Expertise

Self Assessment :
Analytical skills Analyze data Build and manage the Trial Master File (TMF) Control data Create SOPs Design case record forms Develop clinical trial protocols Develop protocols Guide students Interact with nurses Interact with physicians Interpret data Monitor a clinical study Report data Search literature on clinical trials Technology researchAdjust processes Adjust processes and methodsAdministrative supportAdverse event reportingAdvise on strategyAnalyse growth / improvement potentialAnalyze data/information to determine potential relationships.Approve queriesArchive study documentsArchive trial documentation and correspondence.Archive documentationAseptic techniquesAssess adverse reactionsAssist study siteAttend seminarsBuild trial master file (TMF)Clinical data collectionCoachCoach and provide guidance to clinical staff.Coach staffCollaborate with medical teamCollaborate with project teamCommunicate with investigatorCommunicate with sponsorComplete case report form (CRF)Complete study proceduresConduct studiesConduct the trialConfirm protocol compliancecontrol different protocol versions and other essential documentsControl protocol versionsCoordinate projectsCreate clinical documentsCreate clinical project documents according to the protocolCreate SOPsCreate standard operating procedure (SOP)Create study documentsData codingCoordinationData verificationDesign case record form (CRF)Design clinical presentationDesign clinical trialDesign exclusion criteriaDesign inclusion criteriaDesign protocolDesign protocolsDesign studiesDesign studyDesign study documentsDesign subject consent formDesign tracking systemDesign trial master file (TMF)Develop strong internal relationships with stakeholdersDevelop study metricsDevelop training materialsDirect co-workersDirect co-workers to achieve resultDiscuss treatments with investigatorDistribute study documentsEnsure data integrityEnsure data consistencyEnsure good clinical practice (GCP)Identify growth / improvement potentialImplement ProcessesInformed consent processInteract with CROsInteract with KOLInteract with physiciansLead studiesLead teamsLiaise with doctorsLiaise with research teamlifescienceMaintain clinical evaluation reportsMaintenance of biomedical equipmentManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Manage data collection systemManage multiple projectsMonitor Key Performance Indicators (KPI's)NegotiationNetworkObserve trends in dataOral presentationOrganise meetingsOversee data collectionParticipate in medical reviewPeople managementPlanning clinical studiesproject managementProtocol managementProvide trainingQuality control processReport non-compliance incidentsReport serious adverse events (SAE)Resolves queriesRespond to audit findingsReview clinical study reportsReview dataReview medical reportsReview monitoring reportsReview protocolsReview queriesReview reportsReview study protocolsReview vendor metricsReview vendor reportsSerious Adverse Event (SAE) ReconciliationSet up a clinical studySet-up quality policiesSolve problemsStudy-related documentsTrain StaffUnderstand protocolsUpdate Clinical Trials Management System (CTMS) Validate dataVerify data

Education

  • Bachelor of Technology in Clinical Technology (Nephrology) from Central University of Technology in 2004
  • National Diploma in Clinical Technology from Central University of Technology in 2003

Training and Certification

  • Good Clinical Practice for Clinical Trials in 2016 Certification
  • Good Clinical Practice for Clinical Trials in 2015 Certification
  • Good Clinical Practice for Clinical Trials in 2014 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Afrikaans
Native
English
Native
Dutch
Elementary Proficiency
German
Elementary Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Data Manager Clinical Research Associate (CRA) Clinical Supply Manager Clinical Trial Specialist (CTS) Clinical Operations Manager Clinical Trial Manager (CTM) Clinical Trial Coordinator (CTC) associate Clinical Project Manager Application Specialist
  • Locations I am interested in:
    Austria Belgium Czechia Denmark Germany Italy Liechtenstein Luxembourg Netherlands Norway Poland Slovakia Slovenia Sweden Switzerland
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

South Africa

Others

Driving License
  • Yes