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Experiences

Current Experience

  • Freelance Clinical Project Manager / Senior Clinical Research Associate; Proprietor of Business


    Since June 1999
    Project Management, Clinical monitoring conduction of national and international clinical drug and Medical Device trials in germany, austria, switzerland and uk, with a lot of different indications. experience in oncology, Cardiology, Endocrinology, Gastroenterology, CNS and lots others more. specialist for orhphan diseases study stages from start up to close out, Phase II - Phase IV as well as non-interventional trials. ec submission specialist for germany, austria and switzerland. ec submission Medical Devices Project Management, Clinical Monitoring Conduction of national and international clinical drug and medical device trials in Germany, Austria, Switzerland and UK, with a lot of different indications. Experience in Oncology, Cardiology, Endocrinology, Gastroenterology, CNS and lots others more. Specialist for Orhphan Diseases Study stages from start up to close out, phase II - phase IV as well as non-interventional trials. EC submission specialist for Germany, Austria and Switzerland. EC submission Medical Devices

Past Experience

  • Senior Clinical Research Associate (CRA) Home Based

    January 2016 --- April 2016

    senior CRA for non interventional trials in dach region. management of 36 sites in germany, austria and switzerland.

  • Study Start-up Specialist Home based

    February 2015 --- December 2015

    study start up specialist for dach region. submission of several studies with different indications.

  • Freelance sCRA

    September 2008 --- September 2015
    conduction of orphan disease and oncology studies ec, bfs and local authority submissions site management monitoring Stem cell transplantation - pediatric trial Stem cell transplantation in adults renal insufficeny morbus gaucher niemann pick lysosomal strorage diseases autologus chondrocyte implantation

  • Freelance sCRA

    January 2010 --- January 2015
    conduction of a Medical Device study - neuro-stimulation ec submission site management for 3 sites in austria conduction of a rheumatoid arthritis Phase II study site management for 9 sites

  • SSU Site Start Up Specialist

    July 2014 --- December 2014
    regulatory and ethic submissions for germany, austria and switzerland

  • Freelance COM / sCRA

    November 2012 --- August 2014
    Project Management / monitoring for thromboembolism study, Phase III feasibility Budgeting of Investigator payments and vendors contract negociations for sites ec and local authority submissions CRA Training site management for 10 sites

  • Freelance sCRA

    September 2011 --- December 2011
    feasibility for rheumatoid arthritis study in germany.

  • Freelance Clinical Operations Manager

    March 2011 --- November 2011
    Project Management for 3 hyperlipidemia and one acute heart failure trial in start up management of vendors feasibility Budgeting of Investigator payments and vendors contract negociations for sites ec and local authority submissions CRA Training

  • Freelance sCRA

    October 2007 --- December 2008
    conduction of two multipe sclerosis trials in germany feasibility contract negociations ec submission site management for 6 sites

  • Freelance Clinical Operations Manager

    April 2007 --- December 2008
    conduction of a prostate ca study, germany contract negociations for sites ec and local authority submissions site management for 9 sites

  • Freelance Clinical Operations Manager

    April 2005 --- December 2007
    conduction of a basal Cell carcinoma study, austria, switzerland and germany. feasibility Budgeting of Investigator payments and vendors contract negociations for sites ec and local authority submissions

  • Freelance CRA

    March 2006 --- December 2006
    conduction of an Endocrinology study

  • Clinical Research Associate (CRA)

    January 1997 --- December 1998
    CRA responsible for various Phase III studies and non interventional trials

  • Clinical Research Associate (CRA)

    January 1996 --- December 1996
    conduction of a Phase IV Hypertension trial.

  • Product Specialist

    January 1991 --- January 1995
    pre- and post Sales customer care Training for Cell counter systems Training for coagulation systems

Personality

Self Assessment :
Attention to detailAuthenticityAnalytical thinkingCommunicativeCreative thinkingEfficiencyInnovative thinkingInterest in knowledgeProactivityResiliencyOrganizationSelf-disciplineService oriented

Knowledge

Self Assessment :
Medical devices NegotiationAutomation LabtechnicianBudget ManagementBudget NegotiationCancerClinical monitoringClinical Data Management (CDM)Cardiovascular diseasesClinical operationsClinical trial managementCTMSContract negotiationClinical researchDermatologyElectronic Data Capture (EDC) EndocrinologyGastroenterologyGood Clinical Practice (GCP)gHematologyLabtechnicianNephrologyNeurologyoncologyPediatricsProject ManagementRegulatory submissionsRheumatologySupervising CRAs
LinkedIn Assessment :
GastroenterologyClinical researchClinical operationsCROGCPClinical Data ManagementEndocrinologyHypertensionCTMSClinical monitoringRegulatory submissionsEDCICH-GCPNeurologyVaccinesRheumatologyInfectious diseasesCardiologyOrphan DrugsData entryDatabasesCNS disordersMedical DevicesMetabolic DisordersoncologyNeurostimulationLysosomal Storage DiseasesImpotenceProstate CancerGynecologyMetabolic Syndrome

Skills and Expertise

Self Assessment :
Control data Design case record forms Guide students Interpret data Monitor a clinical studyAdministrative supportApprove patient informationAdverse event reportingbudgeting of R&D activitiesApprove queriesCapture data on source documentsDevelop study timelinesDevelop study budgetData codingData entryData verificationCommunicate with investigatorConduct close-out visitsCalculate trial timelinesEnsure good clinical practice (GCP)Gastrointestinal diseasesInitiation visitInteract with CROsInteract with ethics committeeIndentify sitesManage Clinical Trial Management System (CTMS) manage vendorsmanagement ov VendorsMonitoring subject complianceManage Quality Management System (QMS) documentationManage study budgetMonitor clinical trials Negotiate budget Oral presentationOrganise meetingsRead medical literatureRegulatory submissionsReview medical reportsReview monitoring reportsSchedule trial visitsSerious Adverse Event (SAE) ReconciliationSupervise clinical monitorsUse content management systemsValidate data

Education

  • University entry degree in Nutrition Technology from University Weihenstephan in 0000

Training and Certification

  • GCP Training in 2015 Training
  • GCP Training in 2014 Certification
  • Project Managment in 2014 Certification

Languages

BrightOwl Assessment:
Self Assessment:
German
Native
English
Professional Proficiency

Work Preferences

  • Notice Period:
    4 weeks
  • Positions I am interested in:
    Clinical Operations Manager Clinical Project Manager (CPM) Clinical Research Associate (CRA) Lead Consultant
  • Work From Home:
    Yes, 4 to 0 days per week
  • Work Regime:
    BrightOwl freelancer :    32 Hours per week
  • International:
    Yes

Area / Region

Poing, Germany

Others

Driving License
  • Yes

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