Clinical Study Manager (m/f)

Job type:
on-site
Start:
asap
Duration:
24 MM
From:
Hays AG
Place:
Neuchatel
Date:
02/18/2015
Country:
flag_no Switzerland
project ID:
852943

Warning
This project is archived and not active any more.
You will find vacant projects in our project database.

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



Skills:
- Clinical project manager


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