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Global Clinical Trial Manager

Global Clinical Trial Manager (BBBH577233) Lausanne, Suisse

Kelly Life Sciences is looking for its biopharmaceutical partner a:
Global Clinical Trial Manager

Permanent position

Lausanne

100%  Possibility to work from home with weekly visit in the office (Lausanne)

 

Your responsibilities:

  • Lead the overall initiation, coordination, implementation and management of international clinical trials at different stages during mission duration
  • Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met
  • Manage operational and technical aspects of projects including budgeting, timelines and risk management
  • Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation
  • Manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc. You may be involved in the selection process, depending on study status
  • Monitor vendor and CROs performance and ensure continuous oversight
  • Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required
  • Represent clinical operations on multi-function project teams internally and externally, if needed; report on study progress
  • Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans
  • Ensure the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company’s specific SOPs
  • Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents
  • Design, review and approve of all trial related documentation, and establish trial processes.

 

Your profile:

  • Bachelor or Master degree or equivalent in Life Sciences
  • At least 5 years of experience as Global Clinical Trial Manager or comparable operating experience in Pharma (sponsor), including experience leading global Phase I & II studies from set-up to close-out
  • Experience oncology and leading global clinical studies in Phase III is an asset
  • Previous experience in management and Filing of Trial Master File
  • Experience in external audits
  • Excellent knowledge in English. French is an asset

 

Your contact at Kelly:
Mrs Cristina Alvarino
Consultant Professional Staffing Life Science
Kelly Life Sciences Geneva

 

 

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