Clinical Study Manager (m/f)

Job type:
Start date:
20 MM
Hays AG
near Bern
Published at:
flag_no Switzerland
Contact person:
Kerstin Sieber
Project ID:

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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

- Clinical project manager
- Clinical trial manager