Beschreibung
Support for the Development of a Clinical Development Process (CRO) Manual
Role: Support for the Development of a Clinical Development Process (CRO) Manual
Location: Hessen, DE
Start date: 13.02.2017
Planned end date: 17.05.2017
Tasks:
- Interaction with major clinical development functions (Drug Safety, Regulatory Affairs, Clinical Operations,
- Data Management, Biomarker, Medical, etc.) to complete process sections of a CRO manual
- Clarification of responsibilities (CRO vs Sponsor) for outsourced processes
- Constant updating of the manual sections - tracking for responses
- Formatting of the manual
- Set-up of Visio flow charts
Requirements:
- Development/improvement of Clinical Development processes (SOPs, CRO manual)
- Experience with graphic programs (Visio, iGrafx)
- Bonus:
o Clinical Quality Management 0 nice to have
o Clinical Study Management 0 nice to have
For immediate consideration send your updated CV to (see below)