Résumé
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Expertise, Efficiency & Confidentiality |
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Summary of
Qualification
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As a native German speaker, I have been living
in the USA since the late 1990s. My work in the medical and
pharmaceutical industry in Germany and in the US gave me insight and
experience in the European and American regulatory requirements and
clinical procedures, including
the administration
of clinical trials. |
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Self-employed Medical Writer, Editor,
and
Translator, since February 2002 Columbia, MO
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2.5 years experience as a Clinical Data
Coordinator/Clinical Research Associate in San Diego, CA
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7.5 years experience in conducting clinical
trials in Germany, Austria, and Switzerland, including clinical data
management.
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Education
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Master of Science, Biology, June 1986,
Hannover,
Germany
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Ph.D., Pharmacology, November 1989,
Hannover,
Germany |
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Certified in Clinical Trial
Administration, Summer 2001, University of San Diego, CA |
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Core Certificate of the American Medical Writers
Association (AMWA), 2004
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Certificate in Medical Writing and Editing, University of Chicago (Graham
School), 2005
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Board-Certified Editor in the Life Sciences (ELS), March 2006
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Work Experience
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Medical
Writer/Medical
Translator
(self-employed), February 2002 to present
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Preparing medical manuscripts from available
data. |
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Collaborating with
a biotech-company to prepare an IND. |
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Translating and editing
many
medical
and
pharmaceutical documents from English into German (clinical protocols,
patient information, medical publications, package inserts etc.) for
the
pharmaceutical industry, translation agencies, and individuals
throughout the US and Europe.
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Clinical Data Associate,Vical
Inc.,
San Diego, California, September 2001-January 2002
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Data entry activities |
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Moved data from sources, primarily
CRF,
to database (Oracle Clinical).
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Arranged and coordinated all
associated
activities, including logging, tracking, filing, screen development,
etc. |
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Mapped CRF pages to data-entry
screens. |
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Created GLIB questions & DVG's. |
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Defined/Determined validation
checks.
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Data quality assurance activities
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Reviewed and verified that data
entered was identical to the source CRF records.
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Clinical Research
Associate/Clinical Data
Coordinator, ATIMedical, San Diego, California, June
1999 -June
2001
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Designed and programmed clinical
databases in MEDLOG, mapped CRF pages to data entry, entered clinical
data. |
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Developed and reviewed data
management
SOPs. |
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Evaluated data statistically in MEDLOG and EXCEL
(generation of data retrievals and summaries). |
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Monitored medical device studies
(prostate cancer) studies in Germany (Phase I-II). |
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Developed Clinical
Investigator´s Brochures, Patient Consent Forms, Patient
Information Brochures, Case Report Forms in English and German
according to EN 540.
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Wrote White Papers about Prostate
Cancer Treatments (Hyperthermia, Cryotherapy etc.).
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Clinical Research
Associate/Clinical Data
Coordinator, Johnson & Johnson Orthopaedics,
Norderstedt,
Germany, Jan.1992 to Dec.1998
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Set up medical device studies in
the
total joint replacement area in Germany, Switzerland, Austria. These
studies have included regulated studies conducted under the Medical
Device Directive as well as postmarketing surveillance studies. |
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Developed protocols and CRFs. |
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Set up databases using MEDLOG
software. |
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Entered clinical data.
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Issued/resolved queries. |
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Mentored data entry personnel. |
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Evaluated data statistically and
summarized
clinical data with MEDLOG.
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Reported clinical results to
surgeons. |
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Assisted in surgical operations. |
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Trained sales representatives
and
Clinical Research Assistants, assisted in preparing scientific
publications and doctoral theses.
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Regulatory Affairs
Assistant, Ichthyol
Gesellschaft Cordes, Hermanni & Co., Hamburg, Germany, Sept. 1989
to Dec.1991
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Set up pre-and postclinical
documentation for the German Health Authorities. |
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Coordinated drug documentation
with
other in-house departments and company affiliates.
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Trained Sales Representatives.
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Memberships
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Member of BELS (Board of the Editors in the Life Sciences) |
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Member of ATA (American Translation
Association
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Additional Skills
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Languages: German (native language),
English
(First Certificate of Cambridge),
French (Diplome de l´Universite Sorbonne) |
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Computers: IBM PC, Microsoft Office:
Microsoft Word, Microsoft Excel, Microsoft Power Point
MEDLOG (clinical database), Clinical Oracle (clinical database),
Reference Manager (literature database) |