Description
We are looking for a
Clinical Studies Manager (m/f)
Reference: -en
Start: 02/17
Duration: 11 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Provide the operational expertise to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (plan, initiate, conduct, close)
- Ensure adequate sponsor oversight of the clinical studies for their activities
- Contribute to the development and management of the study timelines, risk and quality plans
- Contribute to the creation of the study-level patient recruitment plan and patient retention strategies based on feasibility data
- Coordinate all operational activities required for the collection, delivery, reconciliation and analysis of all bio samples within the assigned clinical study
- Oversee of the monitoring activities on the assigned study(ies)
Your qualifications
- Profound experience in clinical development with proven experience in the operational aspects of all stages of clinical studies, preferably working in a global environment and/or including monitoring
- Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment
- Good knowledge of clinical research and drug development
- In-depth knowledge of GCP (Good Clinical Practice) and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) proficient
- Good written and oral English language skills
- Excellent project management skills (ability to prioritize multiple tasks and goals)
Skills:
- Clinical project manager