Beschreibung
Task:Study Planning activities:
- Site identification
- Support the local study team in performing country and site feasibility
- Trial documentation
- Prepare study files and prepare or co-ordinate the development of any other document required pre-trial
Study start-up activities:
- In liason with the LTM, ensure that the current versions of the required trial documents, trial-related materials
- Support the LTM or, where applicable, the SM in providing the current and complete copies of the documents that the IEC/IRB requests to fulfill its obligation.
Requirements (Must have):
- Experiences to manage FDA Form 1572
- Experiences with Clinical Trial Documentation
- Experiences with documentations requested by IEC/IRB
- German and English fluent
- HCC Experiences
- ICH-GCP Knowledge
- SOP (Standard Operating Procedure) Experiences
Nice to have:
- CTMS - Clinical Trial Management System
Environment/Miscellaneous:
&#% FTE
Beginn: 15.03.2016
Dauer: 15.03.2017
Branche: Medizin/Healthcare