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Summary

i consolidate strong theoretical background to advanced practical experience with regard to coordinating and operational tasks within Clinical research.i extended my Career to a considerable awareness with regard to study management and maintenance of study conduct according gcp-ich aspects.

Experiences

Current Experience

  • Sr./Lead CRA


    Since October 2009
    - coordinating and operational tasks /managing responsibilities - ich gcp /qa expirience - study management - site management: isf, sdv, drug account, psv/siv/imv/cov, eCRF, help sites to serve study expectations - mentoring/Training - preparation of Training material - Investigator meeting lectures - join meetings as Consultant for monitoring activities - process implementation for optimizing monitoring processes - assessment visits/ co-visit - on-site visit: psv,imv,siv,cov - study start up including all activities - icf preparation - contract preparation + negotiations - Regulatory Affairs (ca,irb) - amg studies - btm-studies - bfs-studies - non-interventional trials - post-Marketing trials - risk-based monitoring - systems: impact,clinadmin,credi/etmf oracle,medidatarave, datalabs,ockham, lms,elvis,condor,range etc.... - ms-office - Phase I-iv experience - site invoicing - feasibility - tmf - Coordinating and operational tasks /Managing responsibilities - ICH GCP /QA Expirience - Study Management - Site Management: ISF, SDV, Drug Account, PSV/SIV/IMV/COV, eCRF, help sites to serve study expectations - Mentoring/Training - Preparation of Training Material - Investigator Meeting Lectures - Join Meetings as consultant for monitoring activities - Process implementation for optimizing monitoring processes - Assessment Visits/ Co-Visit - On-Site Visit: PSV,IMV,SIV,COV - Study Start Up including all activities - ICF Preparation - Contract Preparation + Negotiations - Regulatory Affairs (CA,IRB) - AMG Studies - BTM-Studies - BfS-Studies - Non-Interventional Trials - Post-Marketing Trials - Risk-Based Monitoring - Systems: IMPACT,ClinAdmin,CREDI/eTMF Oracle,MedidataRave, DataLabs,Ockham, LMS,Elvis,Condor,Range etc.... - MS-Office - Phase I-IV Experience - Site Invoicing - Feasibility - TMF

Knowledge

LinkedIn Assessment :
Phase II OncologyPhase III-IV CNS (BTM)Phase II CardiovascularPhase II ReproductivePhase II OphthalmologyPhase III-IV RespiratoryPhase I DermatologyPhase I Urology/ Oncology

Education

  • in Applied Biology from Hochschule Bonn-Rhein-Sieg in 0000

Training and Certification

  • Science Degree in 0000 Certification

Area / Region

Berlin, Germany

Others

Driving License
  • Yes

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