\\n My client is an innovating, dynamic and niche growing international pharmaceutical company currently expanding their clinical trial team based in Lausanne area.
Due to this growth my client is looking for a Senior Global Clinical Trial Lead Early phases with strong experience at a global level (including US, Europe or Asia)
Your responsibilities :
- Lead the overall initiation, coordination, implementation and management of international clinical trials at different stages. - 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. - Design, review and approve of all trial related documentation, and establish trial processes - 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. - 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.
Your profile :
- Bachelor or Master degree or equivalent in Life Sciences - Minimum of 5-8 years of experience as Global Clinical Trial Manager within pharmaceutical industry - 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) - Strong negotiation skills, scientific knowledge and involvement - Fluent in English