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Job #02318

About our client Our client is a biotechnology company focused on developing new treatments for markets in oncology and infectious diseases with around three products in clinical development – all targeting multiple oncology indications and infectious diseases. Position Location Lead Project Manager Quebec Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead clinical studies in oncology within the Clinical Affairs division of the company 2) Participate in regulatory submissions, protocol preparation, data analysis, and report preparation 3) Oversee the conduct of clinical studies with respect to budget, timelines, and related activities 4) Manage internal Project Manager(s) 5) Select and oversee the activities of CROs for the conduct of studies (e.g. central laboratory, data management, statistics, monitoring etc. 6) Identify and select clinical investigators 7) Organize and present at investigators’ meetings 8) Prepare and review protocols, consent forms, case report forms, final reports 9) Review regulatory submissions 10) Participate in data interpretation Requirements 1) B.Sc 2) 5-7 years of experience in clinical research 3) 4 years of experience in project management 4) Experience in conducting studies in oncology and people management 5) Knowledge of European regulations a plus 6) Strong knowledge of industry standards with regards to conduct of clinical studies, including ICH/GCP and US, TPD regulatory requirements 7) Excellent leadership skills 8) Superb communication skills 9) Bilingual – English and French 10) Willingness to travel – up to 25%