Clinical Study Manager (m/f)

Job type:
on-site
Start:
asap
Duration:
12 MM+
From:
Hays AG
Place:
near Bern
Date:
02/19/2016
Country:
flag_no Switzerland
project ID:
1074925

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: 12 MM+
Place: near Bern
Branch: Tabakverarbeitung

Your tasks:
  • Coordination of the execution of the assigned clinical studies
  • Lead the Clinical Study Team in all operational aspects of the study, including supervision of the CROs, investigational sites, labs and other external/internal stakeholders involved
  • Coordination of the preparation of study related documents (e.g. Protocol Outlines, Protocols, Informed Consent Forms, Diary Case Record Forms, Study Report etc.)
  • Supervision of monitoring activities, including contribution to the 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
  • Support other Clinical Study Managers in execution of other clinical studies (review of documents, co-monitoring, review of planning/budgets etc.)
  • Support Manager of Clinical Operations in the CRO selection process, including site pre-selection visits, participation in bid defence meetings and assessment of proposals
  • Track the progress of activities contracted to providers and investigators and ensure their completion according to defined quality, timelines and costs
  • Reviews of study budgets, invoices and agreements in close collaboration with the Business Management team
  • Support the Clinical Assessment group in revision/preparation of selected SOPs and document templates
  • Maintain up-to date knowledge of GCPs and relevant regulations


Your qualifications
  • Profound experience in the management of clinical studies, clinical trial monitoring in a pharmaceutical company or a CRO
  • Experience in management studies in USA and Japan
  • Experience in the management of post marketing studies and epidemiological studies is of advantage
  • Fluency in English (oral and written)
  • Strong interpersonal skills and strong team player mentality
  • Proficiency in MS Office, capacity to adapt to other IT tools
  • Knowledge of other languages (e.g. Japanese) is of advantage



Skills:
- Clinical project manager


Keywords: Clinical Project Manager