Clinical Study Manager (m/f)

Job type:
Start date:
24 MM
Hays AG
Published at:
flag_no Switzerland
Contact person:
Kerstin Werner
Project ID:

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We are looking for a
Clinical Study Manager (m/f)

Reference: en
Start: asap
Duration: 24 MM
Place: in Neuchatel
Branch: Tabakverarbeitung

Your tasks:
  • Accountable for planning of activities, monitoring of the progress and coordination and supervision of the CROs (Clinical Research Organisation), investigational sites, labs and other external/internal stakeholders involved in the study execution
  • Monitor Phase I and Phase II
  • Manage the Clinical Study Team and all operational aspects of assigned clinical studies
  • Coordinate the preparation of study-related documents (e.g. protocol outlines, protocols, informed consent forms, diary case record forms, study report etc.)
  • Ensure timely delivery and reviews of documents generated by external parties
  • Contribution to above mentioned documents (input, reviews, quality checks)
  • Responsible for strict supervision of monitoring activities (conducted by CROs monitors) including definition of monitoring plans, review of monitoring reports, follow-up letters and co-monitoring visits
  • Ensure 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
  • Contribute to the Quality Control of all deliverables received from CROs & investigators
  • Maintain up-to-date knowledge of GCPs and relevant regulations and support clinical assessment group in revision/preparation of selected SOPs and document templates

Your qualifications
  • Profound experience in the management of clinical studies, clinical trial monitoring in a pharmaceutical company or a CRO
  • Previous experience in executing studies in the EU, especially in Poland
  • Previous experience in dealing with 2-3 studies in parallel
  • Previous experience in quality assurance/quality control is an asset
  • Fluency in English

- Clinical project manager

Keywords: Clinical Project Manager Phase I Phase II CRO ICH GCP