Description
We are looking for a
Clinical Study Manager (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in Western Switzerland
Branch: Tabakverarbeitung
Your tasks:
- Responsible for implementation and execution of the assigned clinical studies
- Lead of the Study Team and all operational aspects of the study including supervision of the CROs
- Investigational sites, labs and other external/internal stakeholders involved in the study execution
- Contribution and coordination of the preparation of study related documents
- Supervision of monitoring activities including contribution and review of the monitoring plans, review of monitoring reports, follow-up letters and conduct of co-monitoring visits
- Ensure that studies are executed with full adherence to ICH GCP and any relevant guidelines and regulations
- Support Manager of Clinical Operations in selection process of CROs
- Reviews of study budgets, invoices and agreements in close collaboration with Business Management team
- Accountable for the collection of essential documents and completeness of Study Master Files
Your qualifications
- Experience in management of clinical studies
- Previous experience in management of post marketing studies or epidemiological studies is an advantage
- Fluent English (oral and written)
- Strong interpersonal skills and strong team player
- Good knowledge of ICH GCP
- Good knowledge of MS Office
- Working knowledge of electronic document management systems and/or eTMFs
Skills:
- Clinical project manager