/ L'annuaire des offres d'emploi en Suisse Romande

Clinical Study Manager – Temporary position

Entreprise
Kelly Services
Lieu
Suisse romande
Date de publication
31.01.2017
Référence
260423

Description

Kelly Scientific is looking for a Clinical Study Manager – Temporary position within our partner localised in Western part of Switzerland
 
Position Purpose / duties:
 
•       Responsible for implementation and execution of the assigned clinical studies. Lead of the Study Team and all operational aspects of the study including supervision of the CROs (Clinical Research Organization), investigational sites, labs and other external/internal stakeholders involved in the study execution.
•       Contribution (input, reviews, quality checks) and/or coordination of the preparation of study related documents, (including but not limited to IB, 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.
•       Supervision of monitoring activities including contribution and review of the monitoring plans, review of monitoring reports, follow-up letters and conduct of co-monitoring visits.
•       Ensures that studies are executed with full adherence to ICH GCP, Declaration of Helsinki and any relevant guidelines and regulations. Ensures that any compliance issues are escalated to QA / Management and strictly monitors that necessary corrective and preventive actions are put in place.           
•       Supports other Clinical Study Managers in execution of other studies as necessary (review of documents, co-monitoring, review of planning / budgets etc.)
•       Supports Manager of Clinical Operations in selection process of the CROs including site pre-selection visits, participation to bid defense meetings and assessment of proposals.
•       Tracks the progress of activities contracted out to providers and investigators and ensures their completion according to defined quality, timelines and costs.
•       Reviews of study budgets, invoices and agreements in close collaboration with Business Management team
•       Accountable for the collection of essential documents and completeness of Study Master Files. Contributes to the Quality Control of all deliverables received from CROs & investigators.
•       Supports Clinical Assessment group in revision/preparation of selected SOPs and document templates.
•       Maintains up-to date knowledge of GCPs and relevant regulations.
 
Qualifications needed
 
  • Minimum 3 years experience in management of clinical studies
  •  Previous experience in management of studies in the USA and / or in Japan
  •  Previous experience in management of post marketing studies or epidemiological studies is an advantage
  •  Fluent English (oral and written)
  • Strong interpersonal skills and strong team player
  • Good knowledge of ICH GCP
  • Good knowledge of MS Office Suite
  • Working knowledge of electronic document management systems and/or eTMFs
Your contact at Kelly Scientific:
Mathilde DROMARD
PhD in Biology and Health
Consultant Professional Staffing Life Science and Deputy Manager
 

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