Senior Global Clinical Trial Manager Phase 3

Switzerland
Posted 7 months ago

Your responsibilities will be but not limited to:

  • Lead the overall initiation, coordination, implementation and management of Phase III international clinical trial
  • 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
  • Select, 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

Requirements:

  • Bachelor or Master’s degree or equivalent in Life Sciences
  • Proven track record of 5-7 years of experience as Clinical Trial Manager or comparable operating experience in Pharma (sponsor), including experience leading global Phase III studies from set-up to close-out
  • As Clinical Trial Manager, you have worked on various disease areas, including rare disease and oncology
  • Experience in Management and Filing of Trial Master File (Veeva Vault knowledge is a plus)
  • Customer oriented and strong team-spirit with the ability to lead a cross-functional team and foster a collaborative team environment to work effectively with others in a fast-paced matrix organization
  • Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency
  • A first experience in external audits is an asset
  • Strong negotiation skills, scientific knowledge and involvement
  • Former experience in contributing to protocols and clinical development plans
  • Fluent in English – French is an asset
  • Travel up to 20%

Job Features

Job CategoryCLINICAL DEVELOPMENT, LIFE SCIENCES

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