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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)

Past Experience

  • Clinical Research Associate at D-Target / Premier Research Group
    April 2015 --- May 2015
    Clinical Research Associate – Medical Devices • Management 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 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 Management – Medical 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