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Summary

I have successfully completed a bi-lingual Bachelor of Science (Hons) in Clinical Research (First Class) and am currently employed as Associate Project Leader Early Phase at PAREXEL International. In parallel I have completed a certificate in accounting.

The combination of theory and practical experience gained through my studies, my work and my work placements/internships has helped me to gain a broad knowledge of Clinical Research. I am able during my current job to expand my knowledge and I am alwasy eager to learn more.

Please do not hesitate to contact me at any time if you have any questions.

Experiences

Current Experience

  • Associate Project Leader Early Phase Berlin, Germany
    Since February 2014

    Tasks include: - Coordinate and execute setup of the project by requesting resource as required and in close cooperation with the PL - Attend and support coordinating the team and client kick-off meeting in cooperation with the PL - Setup and maintain study specific management tools and Central File Maintenance plan - Set up project-related training as needed for team members in cooperation with PL - Perform quality check of Central Files - Maintain project plans, project status and other administrative reports as well as systems and provide to PL and other internal stakeholders - Support the project such and in cooperation with the PL that it is completed within budget, schedule and according to contract specifications - Attend regular internal team meetings and client meetings - support EC submission and contract negotiation - support of CRAs and review of Monitoring Reports - Organization of Investigator Meeting

Past Experience

  • Student assistant Neuenhagen, Germany
    April 2012 --- January 2014

    Part-time job Tasks include: Data Entry, Data Validation, Query Integration, Archiving, Quality Control, CRF Review, Creation of Data Validation Plan, Testing of Oracle Clinical 5.0, Finalizing of Study Documents (Informed Consent, Protocol, CRF, (S)AE Report Forms)

  • Research Operations Assistant Sydney, New South Wales, Australia
    April 2013 --- August 2013

    Work Placement Global Monitoring Organizations Department Tasks included: Tracking, scanning, photocopying and filing of documents, uploading documents to company or sponsor specific electronic trial master file systems, general upkeep of files and administration, preparing and distribution of site files and study documents, completing transmittal forms, supporting team in Taipei locally with cleaning trial master file Insight into: preparing, conducting and follow-up of monitoring visits, working environment in Australia and Taipei

  • Student assistant Berlin, Germany
    July 2010 --- March 2013

    Part-time job Tasks included: leading and managing the student assistant team, support of American students in any matter, registration and deregistration of students, german tutor, supervision of students during trips and travels, administrative work

  • Student assistant Sofia, Bulgaria
    July 2012 --- August 2012

    Work Placement Tasks included: Co-Monitoring, supporting set up of Data Entry Department and training of employees in first and second Data Entry and Oracle Clinical 4.6

  • Intern Neuenhagen, Germany
    January 2012 --- February 2012

    Internship Tasks included: Creation of CRF and patient information, translation of documents, data entry and validation, archiving, quality control of study reports, CRFs and analytical reports Insight into: Project Management, Regulatory Affairs, Quality Management and Control, Statistic and Data Management

  • Intern Neuenhagen, Germany
    July 2011 --- August 2011

  • Intern
    August 2009 --- August 2009
    Internship Insight into: cloning, mutagenesis, cell cultivating, transfection, protein filtration and immune-blots

Knowledge

Self Assessment :
Ethics submission and approval processContract negotiation monitoring reports
LinkedIn Assessment :
Klinische StudienKlinische ForschungICH-GCPCROMicrosoft OfficeClinical researchTeamworkGute klinische PraxisProject ManagementTime ManagementMicrosoft ExcelClinical trialsRegulatory affairsGCPData ManagementValidationOracle ClinicalClinical monitoringEnglishProjektmanagementDatenverwaltungKlinische ÜberwachungArzneimittelzulassungZeitmanagementData entryAdministrationStatisticsQuality ManagementDiscrepancy ResolutionICFPharmaindustrie

Education

  • Bachelor of Science (BS) in Clinical Research from PAREXEL Academic Institute in 2014

Training and Certification

  • Buchführung und Bilanz (accounting and financial statements) Certification

Languages

BrightOwl Assessment:
Self Assessment:
German
Native
English
Full Proficiency
French
Elementary Proficiency
Spanish
Elementary Proficiency

Area / Region

Deutschland

Others

Driving License
  • Yes