10 days ago on thestamfordgroup.com

Trial Administration Specialist

Stamford Consultants AG

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 Please refer to JobSuchmaschine in your application

Trial Administration Specialist

Ref. # 12448

Our client, a medium sized pharmaceutical company in Basel, Switzerland is looking to hire a Trial Administration Specialist for a one-year contract. 

Key Responsibilities


  • Provide support to the trial team in all phases of the clinical study conduct, including maintaining key information in clinical study systems in accordance with ICH-GCP guidelines, US Food and Drug Administration (US FDA) requirements, and Quality System documents. This position closely collaborates with other team members in addition to the Trial Management Team.
  • Updates and maintains clinical study systems
  • Assists (Global) Trial Manager with clinical study site payments and invoices processing
  • Prepares site related documents (e.g., Investigator Site Files)
  • Prepares, handles, distributes, and files clinical study documentation and reports (e.g., site communication, newsletters, pocket brochures, appendix 16 for the Clinical Study Report)
  • Orders, distributes/ships, and tracks study related non-clinical supplies
  • Works closely with Administrative Support Group for shipments and other routine tasks (e.g., ISF binder preparation)
  • Handles and processes site contracts, including obtaining signatures
  • Requests and handles insurance certificates and policies in cooperation with TM and GCO Group Coordinator
  • Files/uploads documents into systems (e.g. eTMF)
  • Maintains and updates site and user contact lists for External Service Providers
  • Performs administrative tasks to support Trial Management team members with clinical study execution (e.g., Schedule meetings, assist with Investigator meetings, prepare agendas, and meeting minutes)
  • Liaises with other departments, groups and agencies (e.g., printing company, legal department, procurement group)
  • May act as a central contact for the trial team for designated project communications, correspondence, and associated documentation
  • Reviews study reports (e.g., eTMF reports, Interactive Response Technology reports)
  • Performs quality checks of the (e)TMF or other study documents
  • Assists (G)TM with selected tasks in the ESP management
  • Assists at Investigation meetings
  • Reviews study-related reports and discusses necessary actions with the TM
  • Performs quality checks and review of the TMF
  • Audits and resolve issues of redundancy, currency, and consistency of documents on shared drives and portal
Ideal Profile


  • Bachelor’s degree required (in science related discipline preferred) or equivalent education/degree in lifesciences or healthcare; relevant experience may be substituted for degree
  • 2+ years’ experience in a clinical research related position
  • Strong computer skills including proficiency in Microsoft (MS)-based applications (e.g., Word, Excel, and PowerPoint)
  • Knowledge of International Council for Harmonization - Good Clinical Practice (ICH-GCP) guidelines
  • Strong English written and verbal skills
  • Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
  • Working knowledge of electronic Trial Master File (eTMF), clinical trial portals (CTPs) and clinical trial management systems (CTMSs)
  • Ability to find effective solutions when faced with difficult situations and to implement team decisions

If you match the above skill set I look forward to receiving your application, including a motivational letter, via this website.


Please check that your qualifications and experience match the vacancy and that you fill the required criteria. After you have submitted this application form with a current CV, we will endeavour to contact you as soon as we can.

Please submit your CV in Microsoft Word format. We are unable to accept CVs submitted in alternative formats.

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