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Job #02499

About our client Our client is a biotechnology company focused on developing new treatments for under-served markets in oncology and infectious diseases. Position Location Lead Project Manager Montreal, Quebec Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead the clinical development (i.e. oncology or infectious diseases) 2) Ensure all projects are managed as per priorities, budget, and timelines 3) Make sure all data are accurate and reflect ICH/GMP guidelines 4) Manage Direct Reports 5) Lead the planning of clinical studies 6) Oversee the conduct of clinical studies within a portfolio with respect to budget, timelines and related activities 7) Select the activities of CROs for the conduct of studies (e.g. central laboratory, data management, statistics, monitoring, etc.) 8) Oversee selection of clinical investigators 9) Prepare and be present at investigator’s meeting 10) Interpret data, prepare, review, and approve clinical study reports 11) Prepare, review and approve protocols, consent forms, case report forms, study guidelines and, data management, data validation, and statistical analysis plans Requirements 1) B. Sc 2) 8+ years of experience in clinical research 3) Experience in conducting studies in oncology or infectious diseases 4) Knowledge of European Clinical Trial Regulations an asset 5) Excellent knowledge of Word, Excel, and PowerPoint 6) Excellent working knowledge of industry standards with regards to conduct of clinical studies (including ICH/GCP and US, TPD regulatory requirements) 7) Excellent people management skills 8) Superb leadership skills 9) Excellent communication skills – English and French 10) Willingness to travel – up to 25%