Description
We are looking for an
Expert for Development of a Clinical Development Process (CRO) Manual (m/f)
Reference: -en
Start: 02/17
Duration: 3 MM
Place: in Hesse
Branch: Wettbewerber
Your 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
Your qualifications
- Profound knowledge of development/improvement of clinical development processes (SOPs, CRO manual)
- Experience with graphic programs (Visio, iGrafx)
- Experience in clinical quality management and clinical study management highly desirable
- Business-fluent English skills
Skills:
- Clinical project manager