Trial Manager

Reference Number: 895994-W
Type of placement: Contract, 12 months
Location: Switzerland, North West

Introduction:

Our client is a dynamic medium-sized biopharmaceutical company looking for a Trial Manager for a 12 months contract based in the Basel area, Switzerland. The ideal candidate should have 3 years of previous experience performing international clinical trial management with emphasis in phase II-III and vendor management (i.e. CRO, central labs).

Main Responsibilities:

  • Responsible for supporting the operational management and oversight of clinical trials within assigned countries/regions
  • Work closely with Clinical Development trial team to support clinical trial-related activities at the country/site level (site initiations and closures, import/export licenses, Trial Master File (TMF), contracts, and invoices)
  • May participate in the selection, management and training of EPSs
  • Oversee performance of ESPs on a global level to ensure compliance with the clinical study protocol and in accordance with the scope of work (SoW)
  • Proactively identify and resolve issues with ESPs in a timely and efficient manner
  • Contribute to the development and updating of clinical trial-related risk mitigation and contingency plans, and proactively identify new risks
  • Manage and oversee clinical study supplies for assigned countries/regions. May oversee importation of clinical study supplies
  • Oversee clinical trial progress, assist in resolving issues at a country/region level, identify deficiencies in trial conduct, and define and implement required corrections and corrective actions
  • May provide input into the development of Clinical Study Report

Qualifications and Experience:

  • +3 years of demonstrated experience performing international clinical trial management
  • At least 1 year of Phase II-III experience
  • Bachelor's degree or equivalent university education/degree, preferably in life sciences or healthcare
  • Detailed understanding international regulatory requirements for the conduct of clinical development programs in key regions (Americas, Europe, Asia Pacific, and Australia)
  • Experience in managing External Service Providers (ESP) including performance assessments and finance management (invoice review, change order management, budget reforecasting, etc.)
  • Fluent in English; fluency in other languages is preferred
  • Available to travel domestically and internationally
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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