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