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Tina Andersen

Tina Andersen
Tina Andersen
Clinical Process Mgn/CTMS Functional Mng
Cand.mag. Engelsk
Send besked
Tlf. 25403061
Karma: 0 (?)

Leder efter et nyt godt job

Oprettet på K Forum: tirsdag 17. november 2009
Jeg er cand.mag. i engelsk men har de sidste 5 år arbejdet i medicinalindustrien, senest i biotek-firmaet Genmab (jobsøgende nu pga kraftige nedskæringer).

Jeg har opnået rigtig godt praktisk kendskab til research&development og bevæger mig hjemmevant i den medicinske terminologi. Kommunikation har været en ledetråd i mine medicinal jobs - i form af præsentationer, kommunikation på tværs af samarbejdspartnere, manualer, guidelines, infomails, nyhedsbreve samt udgivende redaktør på Genmabs personaleblad. 

Desuden er jeg en formidabel underviser - har været en af de drivende kræfter under implementation og opgradering af vores forsøgshåndteringssystem/CTMS, IMPACT. 
Tidligere har jeg været praktikant på Netavisen Infopaq (Newspaq) og efterfølgende ansat som nyhedsskibent. 

Jeg har løbende skrevet artikler og taget kurser, og har i det hele taget arbejdet mod et informations- eller kommunikationsjob, og er nu klar til udfordringen.

Needless to say; I am perfect in English.

Erfaring

Siden 2008, Clinical Process Manager/CTMS Functional Manager

Keywords: • Implementation of Clinical Trial Management System, IMPACT • Responsible for writing training material, user manuals and guidelines in collaboration with the clinical trial teams • Training of internal and external (CRO) users – face to face or via webex (approximately 200 users worldwide) • Daily CTMS support (ServiceDesk) I have been one of the lead workers in the implementation of IMPACT in Genmab and played a key role in the upgrade to a new version of IMPACT in December 2008, making system configuration; being responsible for the decisions regarding functional changes; coordinating and performing trainings, and updating manuals. Further: • Knowledge of and practical experience with the processes of clinical trials • Standard Operating Procedures – developing, updating and training • Good knowledge of GCP (including Part 11 requirements) • Developing support strategy for IMPACT • Excellent language and communications skills – understand new and complex material fast and can communicate them in an easily understood manner, whether in English or Danish, written or spoken • MS Office user

2006 - 2007, Clinical Trial Administrator

Genmab A/S
Keywords: • Translation of trial-related documents, e.g. protocols, amendments and Patient Information/Informed Consent Forms • Linguistic QC of documents • Responsible for proper handling of all clinical trial documents for the Trial Master File (for Biologic License Application (BLA) trial) • Drug shipment and clinical supply coordinator for BLA trial • IMPACT super-user • Experienced user of electronic document management system (eDoc) • Member of Clinical Process Management group • Meeting planner (Investigator’s Meetings, CRA Training etc)

2005 - 2005, Clinical Trial Assistant

• Proper handling of clinical trial documents- archiving electronically (Documentum and Clinweb) and in TMF • Translation of trial-related documents. I introduced and implemented Medicinordbogen in Organon and was responsible for creating a database of medical terms for Organon’s use • Assistance at monitoring visits at trial sites

2005 - 2005, Translator, subtitler

Softitler
Freelance - April 2005-Dec-2005 Subtitling tv-series etc for DVDs

2005 - 2005, Artikel-skribent

Freelance Marts 2005 – December 2005

2005 - 2006, Campaign worker, English correspondent

Amnesty International
Frivillig, Feb. 2005 – Jun. 2006 Keywords: Oversættelse Pressemeddelser Udvikling af nyhedsbrev om tortur Div. teksproduktion på engelsk

2002 - 2004, Nyhedsskribent

Infopaq, Newspaq
September 2002- September 2004 (inklusiv et halvt år som praktikant)
Uddannelse
Københavns Universitet, Odense Universitet
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