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Summary

i am experienced in Clinical Research Associate, clinical management and start-up management for Medical Device trials. i am actively working in diverse large, multicenter, europe-based and worldwide trials for different Therapeutic Areas like cardiovascluar and Orthopedics, involving several thousand subjects, ranging from pre-market over randomized controlled to post-market registry trials between october 2005 to march 2010 i was working as a Research fellow / post-doc / Doctoral student for a national multi-center study at the German Cancer Research center in heidelberg, germany. during that time, i earned the doctoral degree for human Sciences (dr. sc. hum - phd equivalent) from the medical faculty, University of heidelberg. i participated in Training for clinical studies in oncology in 2007. i was a Member of the graduate program 793 from october 2005 to january 2009 at the University of heidelberg and graduated with a summa cum laude. for my work as Research fellow i was honoured with several awards (stephan-weiland-award 2009 [German Epidemiology association], prevention award 2009 [academy for management and Health], felix-burda-award 2010). the results of my work were published in notable journals like annals of Internal medicine. previously i studied Biology in goettingen from 1999 to 2005. my main topics were Microbiology, immuno Biology and pharmacology. in parallel, i worked part-time as a Medical laboratory assistant in a microbiological Diagnostics laboratory.

Experiences

Current Experience

  • Clinical Manager


    Since December 2011
    Clinical trial management (cm) – Medical Devices, pharma • actively involved as cm in a large multi-center, global investigation including several thousand subjects • backing-up pms in different studies during holiday periods • cooperating with Project Management (pm) on site selection, site initiation and Patient Recruitment, • continuous cooperation with principal investigators as first-line contact for sponsor and site needs / requests • continuous cooperation and oversight of CRA acitivities in site intiation, Patient Recruitment phase, Statistical analyses • continuous Training of new CRA employees and new cras on a project • cooperation with Data Management on database issues • Communication elements between pm and cras • development of tools for activity oversight (progress reports, action item tracker) Clinical Trial Management (CM) – Medical Devices, Pharma • actively involved as CM in a large multi-center, global investigation including several thousand subjects • backing-up PMs in different studies during holiday periods • Cooperating with Project Management (PM) on site selection, site initiation and patient recruitment, • continuous cooperation with principal investigators as first-line contact for sponsor and site needs / requests • Continuous cooperation and oversight of CRA acitivities in site intiation, patient recruitment phase, statistical analyses • Continuous training of new CRA employees and new CRAs on a project • Cooperation with data management on database issues • Communication elements between PM and CRAs • Development of tools for activity oversight (progress reports, action item tracker)

Past Experience

  • Clinical Research Associate at D-Target / Premier Research Group

    April 2015 --- May 2015
    Clinical Research AssociateMedical Devicesmanagement all aspects of a Clinical trials at all assigned clinical sites to ensure Patient Safety, adherence to appropriate safety regulations and data integrity • scientifically monitoring of clinical studies, which includes the review of case report forms (crfs) and source Documentation to ensure adherence to the science)" rel="nofollow">Protocol and consistency and scientific validity of the data • preparation for and conduct of on-site Qualification, study initiation, Interim monitoring and close-out monitoring visits at Investigator sites • maintains/reviews regulatory documents, as required • ensures adherence to study timeline and budget

  • Start-up Manager

    August 2012 --- December 2012
    start-up managementMedical Devices • collection of essential documents, ensuring that local regulations are followed and timelines are met • collection of country-specific requirements • Communication with investigators, Ethics committees and notified bodies • submission of documents to regulatory authorities, ec, review boards

  • Postdoctoral Researcher

    August 2009 --- March 2010
    - conception, design, conduct and Analysis of Research projects in clinical Epidemiology - management of a multi-centre study, data monitoring, data processing, Statistical Analysis, report and publication - conception of the trial: Recruiting of investigators, design of study protocols and documents, writing of sops - conduction of the trial: initiation at trial sites, Training of trial staff and study nurses, in-house and on-site support and motivation, data monitoring, recruitment monitoring, data Documentation, review and report of trial progress - Analysis: Quality Control of data, data processing, Statistical Analysis (using SAS and medcalc), presentation of results at trial sites and meetings / congresses (national and international) - Training of doctoral students / Laboratory staff - writing a proposal for Research grants within the joint programme ‘Clinical trials’ of the dfg (German Research foundation) and the bmbf (German federal ministry of Education and Research)

Knowledge

LinkedIn Assessment :
Medical DevicesCardiovascular DiseaseOrthopedicGastroenterologyStatisticsMedical EducationpharmacologyMicrobiologyImmunologyPublicationsSASEndNotePubMedMedlineAdobe Creative SuiteImmunologieMedizinproduktePharmakologieMikrobiologieStatistik

Education

  • Doctor of Human Sciences / PhD in Epidemiologie from Ruprecht-Karls-Universität Heidelberg / University of Heidelberg in 2009
  • Diploma in Biology (MSc equivalent) in Mircobiology, Immuno Biology, Pharmacology from Georg-August-Universität Göttingen in 2004

Languages

BrightOwl Assessment:
Self Assessment:
German
Native
English
Professional Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Trial Manager (CTM) Project Manager
  • Positions I am NOT interested in:
    Clinical Research Associate (CRA) Senior Clinical Research Associate (CRA)
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    80-100% FTE
  • International:
    Yes

Area / Region

Obernburg am Main, Germany

Others

Driving License
  • Yes

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