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Summary

trial management / lead CRA experience • vendor management • registration of the trial in eudract • managing site contracts and Investigator payments • organizing of kick-off meetings and Investigator meetings • conduct of kick-off meetings and Investigator meetings • Planning, conduct and fu of regular tcs with sponsor • conduct of regular safety tcs with medical monitor(s) and investigators • preparation and conduct of Data Management data/query reconciliation meetings • creation of weekly tracking reports and monthly reports for sponsor • site feasibility Analysis, site selection and all types of site montoring visits (siv to cov) • application for subject trial insurance • control of periodic safety reports to authorities • control of Documentation for Ethics committee submissions including amendments • review of protocols and pics and other essential documents • performing site feasibility assessments with lcra • control of Documentation for regulatory authority submissions including amendments • control of ctaf, substantial amendment notification form • control of regular safety updates and reports to ec • tracking trial supplies i.e Lab kits, leased equipment etc. • preparing for ec audits and inspections by regulatory authorities • working with Clinical trial management systems (impact) • working with medidata rave, ibm Clinical Development • authoring sops

Experiences

Past Experience

  • See Linked in profile

    October 2004 --- January 2017

    see linked in profile: michael joseph roehl

Personality

Self Assessment :
AdaptabilityResiliencySelf-confidence

Knowledge

LinkedIn Assessment :
PowerPointClinical researchReport Writingcardiology researchKlinische StudienPharmaindustrieSOPGute klinische PraxisMedizinprodukteCTMSMicrosoft PowerpointAmerican EnglishMarketingOnkologieStrategische PlanungMicrosoft OfficeGesundheitspflegeTeamentwicklungTeamworkProjektmanagementMicrosoft Word

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Create SOPs Design case record forms Guide students Interact with nurses Interact with physicians Monitor a clinical study Report data Use content management systemsAct as the main line of communication between the sponsor and the investigatorAdjust processes Adjust methodsAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAdministrative support Analyze dataAdminister supply requestAdvise on strategyApprove monitoring reportsApprove patient informationArchive documentationArchive study documentsAssess site feasibilityassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assign activitiesAssist study siteAssist with routine testsAttend investigator meetingAttend seminarsAttend seminars, courses and meetings within and outside the companyAttend steering committeeBuild trial master file (TMF)Calculate timelines for conducting and completing the trialCalculate trial timelinesCoachCoach and provide guidance to clinical staff.Coach clinical staffCoach staffCommunicate with sponsorConduct close-out visitsConduct maintenance visitsConfirm protocol complianceCreate study documentsDirect co-workersEnsure consistency between the protocol and CRFEnsure good clinical practice (GCP)Establish relationships with Key Opinion LeadersEthics committee applicationEstimate subject complianceEthics committee submissionsFeasibility analysis of proposed trial designFollow up projectsFollow-up of external auditsFollow-up of quality assurance activitiesGastrointestinal diseasesIdentify and provide training to trial team and associated staffIdentify investigatorsIdentify sitesIndentify clinicians to conduct clinical trialsLead studiesLead teamsLiaise with doctorsLiaise with doctors and other professionals throughout the studyLiaise with research teamMaintain strong relationshipsManage clinical suppliesManage contractors Manage study budgetMonitor dataMonitoring enrolmentOrganise meetingsPatient recruitmentPlanning clinical studiesproject managementRegulatory submissionsResolves queriesReview reportsScheduling trial visitsSelect investigatorsSelect sitesSet up a clinical studySupervise clinical monitorsUnderstand protocolsWrite documentsWork cross-functionally

Education

  • Clinical Monitor / Clinical Data Manager in Clinical Research from PAREXEL Academy in 2004
  • Bachelor's degree in Economics and German Language from University of Michigan College of Literature, Science, and the Arts in 0000

Training and Certification

  • University of Michigan in 1987 Training
  • Clinical Research Associate / Clinical Data Manager Parexel Akademie Berlin in 2004 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Native
German
Full Proficiency
HEBREW
Elementary Proficiency

Work Preferences

  • Notice Period:
    1 week
  • Positions I am interested in:
    Clinical Research Associate (CRA) Clinical Trial Manager (CTM) Lead
  • Locations I am interested in:
    Germany
  • Work From Home:
    Yes, 0 to 4 days per week
  • Work Regime:
    BrightOwl freelancer :    40 Hours per week :    85 Free Per Month(in coming months)
  • International:
    Yes

Area / Region

Berlin, Germany

Others

Driving License
  • Yes

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