Senior Global Clinical Trial Lead, Oncology Phase I & II

Posted 2 years ago

Key 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 need[1]ed; 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’s degree or equivalent in Life Sciences
  • Proven track record of 5-7 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
  • As Global Clinical Trial Manager, you have worked on various disease areas, including rare disease and oncology (a must)
  • As Global Clinical Trial Manager, you have worked on studies including radiopharmaceutical compounds
  • Experience in leading global clinical studies in Phase III is an asset
  • Experience in pharmacokinetic studies (e.g. DDI, ADME) is an asset
  • 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 foster a collaborative team envi[1]ronment and 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
  • Experience in external audits, 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 maximum 20%

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