Trial Administration Specialist

Inactive

Reference Number: 895867-W
Type of placement: Contract, 12 months
Location: Switzerland, North West

Introduction:

Our client is a leading biopharmaceutical company currently looking for a Trial Administration Specialist, who will assist the Clinical Trial team in the operational management and oversight of clinical trials, during set-up, conduct and until archiving, for an assigned trial.

Main Responsibilities:

  • 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
  • Files/uploads documents into systems
  • Maintains and updates site and user contact lists for External Service Providers (ESPs)
  • 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 (QC) of the (e)TMF or other study documents
  • Assists GTM with selected tasks in the ESP management
  • Assists at Investigation meetings
  • Performs quality checks and review of the TMF in accordance with QS docs
  • Audits and resolve issues of redundancy, currency, and consistency of documents on shared drives and portal

Qualifications and Experience:

  • Minimum of 3 years of clinical research related experience with knowledge of applicable regulations and guidelines, e.g. ICH-GCP
  • Strong computer skills and familiarity with Windows-based applications (e.g., Word, Excel Power Point, and Access)
  • Strong organizational and time management skills
  • Detail oriented with the ability to handle and prioritize multiple tasks
  • Quality conscious
  • Strong English written and verbal skills.
  • Relevant working/residency permit or Swiss/EU-Citizenship required