Frau

9/2011 – 3/2013

- care about specific Projects around the production department and packaging from the pharmaceutical products (instructions of packaging, Instructions of manufacture, controlling from the bill of material and product requirements, At-tendance of meetings and preparation of meeting minutes and Change control tasks)
- administrate the department of Delta 9 (BTM- Dronabinol)
- Project work with special tasks with “Kombistücklisten”

10/2010 – 3/2011

Specific tasks the CTA is responsible for include:
- Perform secretarial duties which include typing correspondence and other ad-ministrative documents and reports related to clinical studies
- Collection, tracking, verification and appropriate dissemination/distribution of essential and other documents
- Organisation of all translations in local language, when required, of all study related documents
- Track and keep records of patient enrollment
- Order, receive and dispatch to investigators study drug supply. Coordinate re-turn and destruction of unused clinical supply
- Requisition of study-related payments
- Maintain unit and clinical trial files

10/2008 – 9/2010

- Coordination of clinical studies phase I-IV and Non Interventional Studies (NIS) with the following indications like leukaemia, cancer and allergy
- care of marketing studies with Botox
- organisation of bigger meetings like Investigator meetings, sponsor meetings and Project meetings as well as internal trainings like Monitoring trainings
- training of new colleagues about contents relevant for studies like TMF-, Inves-tigators file documentation
- documentation and care of the TMF as well as Investigators file for the studies after which I look
- assistance with the submission of the studies for the ethical committee / Ap-prox. (competent Authorities)
- data input and evaluation of patient's data of the CRFs
- Tracking of study material (round faxes)
- communication with different interfaces within the enterprise like partner com-panies in Europe, monitors, Sponsors and third companies (translation compa-nies) into English language
- errands to the various departments (Data management, Medical Writing and Monitoring department)
- constitution and sending of letters and emails into English language
- phone conferences hold with the subsidiaries in Europe in English - material order
- responsibility for the distribution of the internal / external post to the employees within own department