Description
We are looking for a
Clinical Study Manager (m/f)
Reference: -en
Start: asap
Duration: 20 MM
Place: near Bern
Branch: Tabakverarbeitung
Your tasks:
- Accountable for planning of activities, monitoring of the progress and coordination and supervision of the CROs (Clinical Research Organization), investigational sites, labs and other external/internal stakeholders involved in the study execution
- Manages the Clinical Study Team and all operational aspects of assigned clinical studies
- Coordinates the preparation of study related documents, (e.g. Protocol Outlines, Protocols, Informed Consent Forms, Diaries Case Record Forms, Study Report etc.)
- For documents generated by external parties ensures timely delivery and reviews of such documents
- Contribution to above mentioned documents (input, reviews, quality checks)
- Responsible for strict supervision of monitoring activities (conducted by CRO’s monitors) including definition of monitoring plans, review of monitoring reports, follow-up letters and co-monitoring visits
- Ensuring that studies are executed with full adherence to ICH GCP, Declaration of Helsinki and any relevant guidelines and regulations
- Responsible for the collection and of essential documents and completeness of Study Master Files
- Contributes to the Quality Control of all deliverables received from CROs & investigators
- Maintains up-to date knowledge of GCPs and relevant regulations. Supports Clinical Assessment group in revision/preparation of selected SOPs and document templates
Your qualifications
- Profound Experience in management of clinical studies, clinical trial monitoring in a pharmaceutical company or a CRO
- Previous experience in executing studies in USA/Japan
- Previous experience in dealing with 2-3 studies in parallel
- Previous experience in Quality Assurance/Quality Control is an asset
- Fluent in Englisch
Skills:
- Clinical project manager
- Clinical trial manager